WO2019130668A1

WO2019130668A1 - Automated analyzer and automated analysis method

Info

Publication number: WO2019130668A1
Application number: PCT/JP2018/032999
Authority: WO
Inventors: 佑斗風間; 飯島　昌彦; 千枝藪谷; 研二小暮
Original assignee: 株式会社日立ハイテクノロジーズ
Priority date: 2017-12-26
Filing date: 2018-09-06
Publication date: 2019-07-04
Also published as: EP3734288B1; CN111094993A; JP7427732B2; JP6812577B2; US20210405079A1; CN113777338A; EP4293361A2; US20200271677A1; EP3734288A4; JP2021063817A; CN111094993B; JP2022162076A; EP3734288A1; JPWO2019130668A1; JP7130723B2; US11187712B2

Abstract

The present invention makes it possible for an automated analyzer comprising two or more types of photometers to obtain suitable output of the measurement results of the plurality of photometers and suitable data alarm output even if there is an abnormality, or the like, at the time of measurement. This automated analyzer comprises, for example, two types of photometers having different quantitative ranges and an analysis control unit for controlling analysis that includes measurement of a given sample using the two types of photometers. If two types of data alarms corresponding to abnormalities, or the like, during measurement have been added to the two types of measurement results from the two types of photometers (step S204(C)), the analysis control unit selects measurement result and data alarm output corresponding to the combination of the two types of data alarms and outputs the same to a user as analysis results (step S205).

Description

Automatic analyzer and automatic analysis method

The present invention relates to the technology of an automatic analyzer for clinical examination. The present invention also relates to a technique of alarm output in response to an abnormality, an error or the like in an automatic analyzer.

An automatic analyzer for clinical examination detects the concentration and amount of components of a target component substance contained in a sample (also called a sample) such as blood or urine based on optical measurement. As a method of detecting a target component substance, there are many methods using absorption photometry which measures the amount of transmitted light of a sample. In the absorptiometric method, light from a light source is irradiated to a sample or a reaction solution (mixture of a sample and a reagent), and the amount of transmitted light at one or more wavelengths obtained as a result is measured to calculate absorbance. Then, in the absorptiometric method, the component amount of the target component substance is determined from the relationship between the absorbance and the concentration according to the Lambert-Beer law.

In addition, as an automatic analyzer for clinical examination, for example, one that realizes high sensitivity of immunoanalysis using a light scattering detection method using a light amount change of scattered light that easily catches a larger light amount change is known. ing. In the light scattering detection method, light is irradiated to aggregates formed in the antigen-antibody reaction, and at least one of the light amount and the light intensity of the scattered light scattered by the aggregates is measured. Then, in the light scattering detection method, the component amount of the target component substance is determined from the light amount or the relationship between the light intensity and the concentration.

A range in which measurement and quantification are possible (sometimes referred to as "quantitative range", etc.) between an absorptiometer which is a photometer using absorptiometry and a scattering photometer which is a photometer using a light scattering detection method There are differences in the characteristics, including Therefore, in recent years, an automatic analyzer has been developed in which two types of photometers are mounted on one unit and the dynamic range of measurement is expanded by utilizing the difference in the characteristics of the two types of photometers.

As a prior art example regarding the above-mentioned automatic analysis device, JP-A-2014-6160 (patent document 1) is mentioned. Patent Document 1 describes that as an automatic analyzer, an optimum photometer can be determined according to the concentration range among a scattering photometer and an absorptiometer.

JP, 2014-6160, A

By the way, many automatic analyzers for clinical examination have a function (which may be described as a data alarm function) for outputting an alarm as described below in order to improve the reliability of the measurement result. In this function, an abnormality or error in measurement is monitored, and when it is detected, predetermined data representing the type of the abnormality or the like is appended to the measurement result information as a data alarm and output.

If an abnormality or the like at the time of measurement is minor, for example, re-measurement etc. may be performed after coping with dilution of the sample, for example, so that an appropriate measurement result may be obtained. Therefore, there has also been developed an automatic analyzer having a function (which may be referred to as an automatic re-examination function) of performing re-examination including re-measurement automatically according to the abnormality or the like.

For example, in the automatic analyzer of Patent Document 1, there is disclosed a method of selecting an output from measurement results of two types of photometers in the case of normal measurement, in other words, when an abnormality or the like is not detected. However, in an automatic analyzer equipped with two or more types of photometers and having a data alarm function and a function to select measurement results, etc., if there is an abnormality at the time of measurement, two or more types of measurement results It is unexamined how it is preferable to select an output from the and data alarms. For example, in the case of analysis using two types of photometers, an abnormality or the like is detected in the measurement of each photometer, and a case may occur in which each data alarm is added to both of the two types of measurement results. obtain. That is, two or more types of multiple data alarms may occur simultaneously. In that case, it was unclear how to select the output for the user.

In the above-mentioned automatic analyzer, when outputting all of a plurality of types of measurement results and data alarms, or when selecting and outputting one measurement result and data alarms, it may be difficult for the user to judge in any case. is there. It is difficult for the user to understand what kind of state or meaning the output represents, and it is necessary to judge whether the measurement is correct or incorrect, reexamination, necessity of reexamination work, etc. And operations are required. That is, in the above-mentioned automatic analysis device, the load on the user against the output is large, and there is a possibility that a judgment error, a delay in result report, etc. may occur.

Also, considering the combination with the automatic retesting function in the above-mentioned automatic analyzer, we have not yet considered how to control the remeasurement when two or more types of multiple data alarms occur. Therefore, the automatic retesting function can not be used effectively.

The object of the present invention relates to the technology of an automatic analyzer comprising two or more kinds of plural photometers, and it is possible to obtain a suitable output from measurement results and data alarms of plural photometers even when there is an abnormality at the time of measurement. It is to provide technology that can be realized. That is, the present invention is to provide a technology capable of reducing the load of the user on the output and preventing a determination error, a delay in the result report, and the like. In addition, another object of the present invention is to provide a technique capable of realizing more accurate measurement at high speed by suitable re-measurement control even in the case of an automatic analyzer having an automatic re-inspection function.

A representative embodiment of the present invention is an automatic analyzer, which is characterized by having the following configuration. The automatic analyzer according to one embodiment includes a plurality of types of photometers having different quantitation ranges, and an analysis control unit that controls analysis including measurement using the plurality of photometers of a target sample. The analysis control unit acquires a plurality of measurement results including a plurality of measurement values using the plurality of photometers, and when an abnormality is detected in the measurement using the plurality of photometers, When a data alarm according to the type of the abnormality is added to the measurement result using the corresponding photometer among the plurality of measurement results, and a plurality of data alarms are added to the plurality of measurement results, From the plurality of measurement results and the plurality of data alarms, the measurement results and the data alarm to be output are selected according to the combination of the plurality of data alarms, and the selected measurement results and the data And outputs to the user as an analysis result arm.

According to a typical embodiment of the present invention, regarding the technology of an automatic analyzer provided with two or more types of plural photometers, measurement results of plural photometers and even when there is an abnormality or the like at the time of measurement Favorable output from data alarm can be realized. That is, it is possible to reduce the load of the user on the output, and to prevent a determination error, a delay in the result report and the like. Further, according to the representative embodiment, even in the case of an automatic analyzer having an automatic retesting function, more accurate measurement can be realized at high speed by the control of suitable remeasurement.

It is a figure which shows the whole schematic structure of the automatic analyzer of Embodiment 1 of this invention. FIG. 2 is a diagram mainly showing a functional block configuration of an analysis control unit in the automatic analyzer of the first embodiment. FIG. 2 is a view showing characteristics of two types of photometers in the automatic analyzer of the first embodiment. FIG. 6 is a view showing a table of classification definitions of data alarms in the automatic analyzer of the first embodiment. FIG. 7 is a diagram showing a first part as a correspondence table between data alarms and outputs in the automatic analyzer of the first embodiment. FIG. 7 is a view showing a second part as a correspondence table in the automatic analyzer of the first embodiment. It is a figure which shows the 3rd part by the automatic analyzer of Embodiment 1 as a corresponding | compatible table. FIG. 7 is a view showing a fourth part as a correspondence table in the automatic analyzer of the first embodiment. FIG. 6 is a diagram showing a flow of output control processing in the automatic analyzer of the first embodiment. FIG. 8 is a diagram showing a flow of priority output alarm determination processing in the first embodiment. In Embodiment 1, it is a figure which shows the flow of high level data alarm processing. In Embodiment 1, it is a figure showing the flow of the 1st portion of middle level data alarm processing. In Embodiment 1, it is a figure showing the flow of the 2nd part of middle level data alarm processing. In Embodiment 1, it is a figure which shows the flow of a low level data alarm process. FIG. It is a figure which shows the example of a processing flow in the automatic analyzer of Embodiment 2 of this invention. It is a figure which shows the flow of the 1st part of a middle level data alarm process in the automatic analyzer of Embodiment 3 of this invention. In Embodiment 3, it is a figure which shows the flow of the 2nd part of middle level data alarm processing.

Hereinafter, embodiments of the present invention will be described in detail based on the drawings. Note that, in all the drawings for describing the embodiment, the same reference numeral is attached to the same part in principle, and the repeated description thereof will be omitted.

[Issues etc]
Supplementary explanation of assumptions and issues. The reaction between the sample and the reagent is roughly divided into two types, a color reaction and an agglutination reaction. The color reaction is a reaction between a substrate and an enzyme, and is used in biochemical analysis. In biochemical analysis, the amount of absorption of light (expressed as absorbance) by the colored reaction solution is measured to determine the amount of components. The agglutination reaction is a reaction between an antigen and an antibody, and is used in an immunoassay. In the immunoassay, the turbidity (represented as turbidity) of the reaction solution, which changes due to the aggregation of the antigen and the antibody, is measured from the change in the amount of transmitted light to determine the amount of components. The target component substance to be measured by immunoassay usually has a low blood concentration, and a highly sensitive detection system is required. Therefore, latex immunoassay and the like have been developed for immunoassays. In the latex immunoturbidimetric method, the turbidity change is made larger by increasing the size of the aggregate formed by the antigen-antibody reaction using a reagent in which the antibody or antigen is sensitized and bound to the latex particle surface, and the sensitivity is high. Measurement is possible.

The light scattering detection method generally has high detection sensitivity and good quantitativity for low concentration samples, but has many aggregates in high concentration samples and is not good for quantitative analysis due to the influence of multiple scattering. On the other hand, absorption photometry generally does not have high detection sensitivity for low concentration samples, but it has better quantitativity for high concentration samples compared to light scattering detection methods, and a wide concentration range that can be quantified. As described above, there are differences in characteristics between the absorptiometer, which is a photometer using absorptiometry, and the scattering photometer, which is a photometer using a light scattering detection method, as described above. Therefore, in recent years, an automatic analyzer has been developed in which two types of photometers are mounted on one unit and the dynamic range of measurement is expanded by utilizing the difference in the characteristics of the two types of photometers. In this automatic analyzer, for example, the measurement results of the scattering photometer are used in the low concentration region, and the measurement results of the absorptiometer are used in the high concentration region.

Patent Document 1 discloses a method of selecting a photometer with high sensitivity based on variations in measured values of a standard solution used to create a calibration curve of each photometer, as a selection criterion of the photometer. Further, a method is disclosed in which a plurality of concentration ranges are set in advance, and two types of photometers are switched according to the concentration range to which the measured value of the photometer falls.

As an automatic analyzer according to a comparative example of the embodiment of the present invention, an automatic analyzer comprising an absorptiometer using absorption photometry and a scattering photometer using a light scattering detection method will be considered as two conventional photometers. Moreover, in this automatic analyzer, it is assumed that it has a simultaneous analysis function which is a function which measures and analyzes simultaneously using two types of photometers. In addition, this automatic analyzer is assumed to have a data alarm function which is a function of appending a data alarm to the measurement result in accordance with detection of abnormality or the like at the time of measurement. Further, this automatic analyzer has a function of selecting and outputting one of suitable measurement results based on a predetermined judgment from the measurement results of two types of photometers in simultaneous analysis. As the judgment criteria and method for selecting the output, for example, there is a method of selecting the measurement result of the photometer having a suitable quantitative range for the concentration of the target sample.

However, in the automatic analyzer of this comparative example, when there is an abnormality or the like at the time of measurement at the time of simultaneous analysis, two types of data alarms may occur along with the two types of measurement results. Measurement results and data alarms are obtained independently for the absorptiometer and the scatterometer, respectively. In this case, conventionally, it has not been examined how it is preferable to select the measurement result and the data alarm to be output from the two types of measurement results and the data alarm. In the apparatus of the comparative example, when the above two types of measurement results and data alarms occur, selecting and outputting the measurement results and data alarms with lower reliability means that the user has made a mistake or a result report It is not desirable because it leads to delays and the like.

Embodiment 1
The automatic analyzer and the automatic analysis method according to the first embodiment of the present invention will be described with reference to FIGS. The automatic analysis method according to the first embodiment is a method including the steps performed in the automatic analysis device according to the first embodiment.

The automatic analyzer according to the first embodiment includes an absorptiometer and a scatterometer as two types of photometers, and has a data alarm function and a simultaneous analysis function. The data alarm function is a function to add a data alarm according to the abnormality or the like to the measurement result when an abnormality or the like at the time of measurement is detected. The simultaneous analysis function is a function to simultaneously perform measurement and analysis ("simultaneous light absorption / scattering analysis") using two types of photometers. The automatic analyzer according to the first embodiment has a function of selecting a suitable measurement result from a plurality of measurement results according to a target component substance of a test item and a suitable quantitative range of various photometers in simultaneous analysis. It can be measured with a wide dynamic range.

The automatic analyzer according to the first embodiment suitably selects the measurement result and the data alarm even when two types of measurement result and data alarm are obtained according to the abnormality at the time of measurement, etc. at the time of simultaneous analysis. Output function (sometimes referred to as output control function). In this function, the measurement result to be output, the data alarm, etc. are suitably selected according to the combination of the data alarm. The measurement results include quantitative values such as measured values and calculated values, signal values, analysis result information, and the like.

Furthermore, the automatic analyzer according to the first embodiment also has an automatic retesting function, and even if two types of measurement results and data alarms are obtained as described above, the above-mentioned output control function suitably controls the automatic retesting. Do. That is, the automatic analyzer according to the first embodiment suitably selects the measurement result to be output, the data alarm, and the automatic retest information according to the combination of the data alarm, and controls the automatic remeasurement and the like. The automatic retest information includes the necessity of automatic retest, identification information of a photometer to be used, remeasurement conditions (for example, conditions such as dilution of a sample), and the like.

[Analyzer]
FIG. 1 shows the entire schematic configuration of the automatic analyzer 1 of the first embodiment. The automatic analyzer 1 includes a sample disk 10, a reaction disk 20, a reagent disk 30, a sample dispensing mechanism 41, a reagent dispensing mechanism 42, a computer 100, an interface circuit 101, and the like. The sample disc 10 is provided with a drive unit 12. The reaction disk 20 is provided with a drive unit 22. The reagent disc 30 is provided with a drive unit 32. Further, on the reaction disk 20, two types of photometers, an absorptiometer 44 and a scattering photometer 45, are installed. In addition, the reaction disk 20 is provided with a thermostatic chamber 28. Further, on the reaction disk 20, a stirring unit 43, a washing unit 46 and the like are installed.

The computer 100 includes an analysis control unit 50, a storage unit 70, an output unit 71, an input unit 72, and the like. The analysis control unit 50 is connected to each drive unit and each mechanism through an interface circuit 101 including a signal line and the like. The computer 100 is configured by, for example, a PC, but is not limited to this. The computer 100 may be configured by a circuit board such as an LSI substrate, or may be configured by a combination thereof. The storage unit 70 is configured of a storage device such as a ROM, a RAM, and a non-volatile storage device.

On the sample disk 10, a plurality of sample cups 15 are installed and held. The sample cup 15 is a sample container for storing the sample 2. The sample cups 15 are held on the disk body 11 of the sample disk 10 so as to be spaced apart from one another along the circumferential direction.

The drive unit 12 of the sample disk 10 drives and controls the sample disk 10 according to the control from the analysis control unit 50 (the control unit 53 in FIG. 2). At this time, the drive unit 12 rotates the disc main body 11 to move the plurality of sample cups 15 along the circumferential direction. The sample disc 10 arranges one sample cup 15 out of the plurality of sample cups 15 installed in the disc main body 11 at a predetermined position along the circumferential direction by drive control of the drive unit 12. The predetermined position is, for example, a sample suction position by the sample dispensing mechanism 41 or the like.

In the configuration example of FIG. 1, in the sample disc 10, a plurality of sample cups 15 are arranged on the disc main body 11 in a row along the circumferential direction. Not limited to this, the sample cups 15 may be arranged in a plurality of rows concentrically with the disc main body 11. Further, although the configuration example of FIG. 1 includes the sample disc 15 of the disc type, the present invention is not limited to this and may be a rack type. The rack system uses a sample rack in which a plurality of sample containers are arranged and held in one or two dimensions.

The reagent disc 30 is placed next to the reaction disc 20. A plurality of reagent bottles 35 are installed and held in the disk body 31 of the reagent disk 30. The reagent bottle 35 is a reagent container for containing the reagent 4. The respective reagent bottles 35 are spaced apart from one another along the circumferential direction of the disk main body 31 and held in parallel. The reagent bottle 35 contains the reagent 4 of the type according to the target component substance of the inspection item in the automatic analyzer 1. Each type of reagent 4 is housed in a separate reagent bottle 35.

The drive unit 32 of the reagent disc 30 rotates the disc main body 31 under the control of the analysis control unit 50 to move the plurality of reagent bottles 35 along the circumferential direction. The reagent disc 30 arranges one reagent bottle 35 of the plurality of reagent bottles 35 installed in the disc main body 31 at a predetermined position of the reagent disc 30 by the drive control of the drive unit 32. The predetermined position is, for example, a reagent suction position by the reagent dispensing mechanism 42 or the like.

The reagent disk 30 is provided with a reagent storage 38 provided with a cooling mechanism. The plurality of reagent bottles 35 disposed on the disc main body 31 is cooled in a state where it is always kept in the cooling environment of the reagent storage container 38 even when the disc main body 31 rotates. Thereby, deterioration of the reagent 4 is prevented. As a cooling mechanism of the reagent cooler 38, for example, a method of circulating low temperature water, or a method of cooling in a gas phase by a Peltier element or the like is used.

The reaction disc 20 is disposed between the sample disc 10 and the reagent disc 30. A plurality of reaction containers 25 are installed and held on the disk body 21 of the reaction disk 20. The reaction container 25 is a container in which the reaction liquid 3 is produced. The reaction solution 3 is a mixture of the sample 2 and the reagent 4. The sample 2 is dispensed into the reaction container 25 by the sample dispensing mechanism 41, the reagent 4 is dispensed by the reagent dispensing mechanism 42, and the reaction liquid 3 is produced from a mixture of the sample 2 and the reagent 4. The reaction vessels 25 are spaced apart from one another along the circumferential direction of the disk body 21 and held in parallel. The reaction vessel 25 is made of a translucent material for measurement by the absorptiometer 44 and the scattering photometer 45. Under the control of the analysis control unit 50, the drive unit 22 of the reaction disk 20 rotates the disk body 21 to move the plurality of reaction containers 25 along the circumferential direction. The reaction disk 20 arranges one reaction container 25 of the plurality of reaction containers 25 at a predetermined position provided along the circumferential direction by the rotation of the disk main body 21. The predetermined position is, for example, a sample discharge position by the sample dispensing mechanism 41, a reagent discharge position by the reagent dispensing mechanism 42, or the like.

Each of the plurality of reaction containers 25 disposed on the disk body 21 of the reaction disk 20 is constantly immersed in constant temperature water (also referred to as constant temperature fluid) in the constant temperature chamber 28. Thereby, the reaction liquid 3 in the reaction vessel 25 is maintained at a constant reaction temperature (for example, about 37 ° C.). The temperature and flow rate of the constant temperature bath water in the constant temperature bath 28 are controlled by the analysis control unit 50 (the constant temperature fluid control unit 54 of FIG. 2), and the amount of heat supplied to the reaction container 25 is controlled.

In addition to the sample dispensing mechanism 41 and the reagent dispensing mechanism 42, the stirring portion 43, the absorptiometer 44, the scattering photometer 45, and the washing portion are provided on the circumference and around the circumference of the reaction disc 20, with different positions. 46 mag is placed.

The sample dispensing mechanism 41 is disposed between the sample disc 10 and the reaction disc 20. The sample dispensing mechanism 41 sucks the sample 2 from the sample cup 15 at the sample suction position of the sample disk 10 and discharges the sample 2 to the reaction container 25 at the sample discharge position of the reaction disk 20. The sample dispensing mechanism 41 includes a movable arm and a dispensing nozzle. The dispensing nozzle consists of a pipette nozzle attached to the moveable arm. During the sample dispensing operation, the sample dispensing mechanism 41 moves the dispensing nozzle to the sample suction position on the sample disk 10, and a predetermined amount of sample is placed in the dispensing nozzle from the sample cup 15 disposed at the sample suction position. Inhale sample 2 and store. Thereafter, the sample dispensing mechanism 41 moves the dispensing nozzle to the sample discharge position on the reaction disk 20, and discharges the sample 2 in the dispensing nozzle into the reaction container 25 disposed at the sample discharge position.

The reagent dispensing mechanism 42 is disposed between the reagent disc 30 and the reaction disc 20. The reagent dispensing mechanism 42 sucks the reagent 4 from the reagent bottle 35 at the reagent suction position of the reagent disc 30, and discharges the reagent 4 to the reaction container 25 at the reagent discharge position of the reaction disc 20. The reagent 4 to be dispensed is a reagent used for quantifying the target component substance which is an analysis item (also called a test item etc.) set corresponding to the target sample 2. The reagent dispensing mechanism 42 similarly includes a movable arm and a dispensing nozzle. The reagent dispensing mechanism 42 moves the dispensing nozzle to the reagent aspirating position on the reagent disc 30 during the reagent dispensing operation, and a predetermined amount of reagent from the reagent bottle 35 disposed at the reagent aspirating position into the dispensing nozzle 4 Inhale and store. Thereafter, the reagent dispensing mechanism 42 moves the dispensing nozzle to the reagent discharge position on the reaction disk 20, and discharges the reagent 4 in the dispensing nozzle into the reaction container 25 disposed at the reagent discharge position.

Each of the sample dispensing mechanism 41 and the reagent dispensing mechanism 42 is provided with a washing tank 46 in preparation for dispensing different types of samples 2 or reagents 4. The cleaning tank 46 is a mechanism for cleaning the dispensing nozzle. Each dispensing mechanism cleans each dispensing nozzle with the cleaning tank 46 before and after the dispensing operation. This prevents contamination of the samples 2 or of the reagents 4 with each other. Further, the dispensing nozzle of each dispensing mechanism is equipped with a sensor for detecting the liquid level of the sample 2 or the reagent 4. As a result, it is possible to monitor and detect measurement abnormalities due to the shortage of the sample 2 or the reagent 4. In addition, the sample dispensing mechanism 41 is equipped with a pressure sensor that detects clogging of the dispensing nozzle. In this way, it is possible to monitor and detect a dispensing abnormality that occurs when an insoluble substance such as fibrin contained in the sample 2 clogs the dispensing nozzle. The analysis control unit 50 can monitor and detect various abnormalities and the like at the time of measurement through a mechanism including those sensors.

The stirring unit 43 stirs the mixed solution of the sample 2 and the reagent 4 in the reaction container 25 disposed at a stirring position which is a predetermined position on the reaction disk 20. Thereby, the liquid mixture in the reaction vessel 25 is uniformly stirred, the reaction is promoted, and the reaction liquid 3 is prepared. The stirring unit 43 includes, for example, a stirrer provided with a stirring blade or a stirring mechanism using ultrasonic waves.

In two types of photometers, it has one absorptiometer 44 as a first type photometer and has one scattering photometer 45 as a second type photometer. Each photometer of the absorptiometer 44 and the scattering photometer 45 has a light source and a light receiver as a basic structure. The light source of each photometer, for example, is disposed on the inner peripheral side of the reaction disc 20, and the light receiving unit of each photometer is disposed on the outer peripheral side of the reaction disc 20. Each photometer is connected to the analysis control unit 50 (measurement unit 51 in FIG. 2).

The absorptiometer 44 measures the reaction liquid 3 of the reaction container 25 disposed at a measurement position (in particular, the first measurement position) which is a predetermined position on the reaction disc 20. The scattering photometer 45 measures the reaction liquid 3 of the reaction container 25 disposed at a measurement position (in particular, a second measurement position) which is a predetermined position on the reaction disk 20. In the configuration example of FIG. 1, the two photometers of the absorptiometer 44 and the scattering photometer 45 are disposed at predetermined positions on the circumference of the reaction disc 20 diagonally opposite to the center of rotation of the reaction disc 20. ing. An absorptiometer 44 is disposed for the first measurement position, and a scattering photometer 45 is disposed for the second measurement position. In addition, the stirring part 43 and the washing | cleaning part 46 are arrange | positioned on the circumference | surroundings and the predetermined position between a 1st measurement position and a 2nd measurement position.

The absorptiometer 44 irradiates light from the light source to the reaction liquid 3 of the reaction container 25 at the first measurement position. At that time, the absorptiometer 44 detects the transmitted light obtained from the reaction solution 3 by the light receiving unit, and describes at least one of the light amount or the light intensity of the transmitted light of a single or plural wavelengths (light amount / light intensity There are cases) to measure. Moreover, the absorptiometer 44 may obtain quantitative values, such as concentration, by predetermined calculation based on the measured value. The absorptiometer 44 outputs a signal containing measured or calculated values.

The scattering photometer 45 irradiates light from the light source to the reaction liquid 3 of the reaction container 25 at the second measurement position. At that time, the scattering photometer 45 detects the scattered light obtained from the reaction solution 3 by the light receiving unit, and measures at least one of the light amount or the light intensity (light amount / light intensity) of the scattered light. In addition, the scattering photometer 45 may obtain a quantitative value such as concentration by a predetermined calculation based on the measured value. The scatterometer 45 outputs a signal including measured or calculated values.

The cleaning unit 46 cleans the reaction container 25 disposed at the cleaning position on the reaction disk 20. The washing unit 46 discharges the remaining reaction liquid 3 from the reaction container 25 in which the measurement and analysis are completed, and cleans the reaction container 25. The cleaned reaction container 25 can be reused. That is, the next sample 2 is dispensed from the sample dispensing mechanism 41 to the reaction container 25 again, and the next reagent 4 is dispensed from the reagent dispensing mechanism 42.

[Analysis control unit]
FIG. 2 mainly shows a functional block configuration of the analysis control unit 50 in the configuration of FIG. The analysis control unit 50 controls the whole of the automatic analyzer 1 and the automatic analysis sequence, and controls the analysis including the measurement. The analysis control unit 50 is connected to the interface circuit 101, the output unit 71, the input unit 72, and the like. The analysis control unit 50 performs output (that is, screen display, audio output, and the like) to the output unit 71. The analysis control unit 50 receives an input from the input unit 72 (that is, an operation or the like by the user). The user of the automatic analyzer 1 performs operations and tasks related to the clinical examination through the output unit 71 and the input unit 72. The output unit 71 includes an output device such as a display device. Information such as a measurement result and a data alarm is displayed on the display screen of the display device by the output control of the analysis control unit 50. The output unit 71 may include an audio output device, and may emit an alarm sound. The input unit 72 includes an input device such as a keyboard, a mouse, or an operation panel including operation buttons.

Although the computer 100 and the analysis control unit 50 can be integrally realized by a PC as an implementation example, the present invention is not limited to this and can be implemented. The analysis control unit 50 executes processing according to a program read from the storage unit 70 by a microprocessor such as a CPU of a PC, for example. Thus, each unit such as the measurement unit 51 is realized. The analysis control unit 50 is a functional block realized by software program processing etc., and the measurement unit 51, the analysis unit 52, the control unit 53, the constant temperature fluid control unit 54, the data storage unit 55, the simultaneous analysis determination unit 56, the automatic retest determination The unit 57 includes a measurement abnormality check unit 58, a priority output determination unit 59, and a priority output alarm determination unit 60. The analysis control unit 50 controls various functions including a simultaneous analysis function described later, a measurement result selection function, a data alarm function, an output control function, and an automatic retest function. The analysis control unit 50 mainly controls the operation control process and measurement of each mechanism and part of the automatic analyzer 1 as an analysis process for the sample 2 for which analysis has been requested by the measurement unit 51, the analysis unit 52, and the control unit 53. Perform data control processing etc.

The data storage unit 55 is configured using the storage unit 70, and reads and writes various data. The data storage unit 55 stores various data related to analysis, including measurement results, data alarms, and automatic retest information.

The measurement unit 51 inputs a signal including the measurement values of the absorptiometer 44 and the scattered light clock 45 which are two types of photometers, and performs measurement processing. This measurement process includes predetermined calculations. This calculation is, for example, calculating the concentration of the target component substance based on the light quantity / light intensity which is a measured value, or calculating the light intensity from the light quantity which is a measured value. The measurement unit 51 stores the measurement result (measurement value or calculation value) in the data storage unit 55 as measurement data.

The analysis unit 52 performs analysis processing corresponding to automatic analysis with reference to measurement data of the measurement result of the data storage unit 55. This analysis process is, for example, to calculate the concentration from the light intensity of the measurement data using a calibration curve. Alternatively, this analysis process is to calculate the component amount of the target component substance using the calculated concentration. Further, the analysis unit 52 determines, for each measurement result of each type of photometer, whether there is an abnormality or the like at the time of measurement, and if there is an abnormality or the like, data representing the abnormality or the like in the measurement result Add an alarm. The determination by the analysis unit 52 is an independent determination for each type of photometer. The analysis unit 52 makes the determination with reference to the control result information and the like stored in the data storage unit 55 by the control unit 53 when making a determination such as an abnormality at the time of measurement.

The control unit 53 is a drive control unit that performs drive control of each mechanism according to the automatic analysis sequence. The control unit 53 performs drive control based on the analysis request information and the like of the target sample 2 stored in the data storage unit 55. The control unit 53 controls each portion including each mechanism such as the drive unit 12, the drive unit 22, the drive unit 32, the sample dispensing mechanism 41, the reagent dispensing mechanism 42, the absorptiometer 44, and the scattered light watch 45. For example, the drive unit 12 drives and rotates the sample disk 10 according to the control from the control unit 53. Further, for example, the control unit 53 drives and controls the sample dispensing mechanism 41 to perform a sample dispensing operation. Further, for example, the control unit 53 drives and controls the absorptiometer 44 to perform measurement at each measurement point of a predetermined period. The control unit 53 controls the operation of each part at the time of analysis, and stores control result information representing the control state and result in the data storage unit 55. When there is an abnormality or the like in the mechanism or when an abnormality or the like is detected by the mechanism, the control result information includes information representing the abnormality or the like.

The control unit 53 rotates each disc such as the sample disc 10 and arranges a container such as a target sample cup 15 at a predetermined position of each disc. By rotation of the disc, each container repeats rotational movement of a unit distance and rest on the circumference. The control unit 53 produces the reaction solution 3 of each of the plurality of respective specimens 2 in each of the plurality of reaction containers 25 on the reaction disk 20 by controlling the operation of each of the disks and the specimen dispensing mechanism 41 and the like. Then, in the case of simultaneous analysis, the control unit 53 measures the light intensity / light intensity of the reaction liquid 3 of the target reaction container 25 disposed at each measurement position on the reaction disk 20 by control of two types of photometers. Let me do it.

The constant temperature fluid control unit 54 controls the temperature and flow rate of the constant temperature bath water in the constant temperature bath 28 of the reaction disk 20 to adjust the temperature of the reaction liquid 3 in the reaction container 25.

The simultaneous analysis determination unit 56 makes a determination for output control based on the measurement results of the two types of photometers in the case of the simultaneous analysis and the data alarm. In other words, the automatic reinspection determination unit 57 is an abnormality etc. determination unit, and determines the necessity or the like of the automatic reinspection based on an abnormality or the like at the time of measurement for the measurement result using one type of photometer. The measurement abnormality check unit 58 determines and checks whether or not an abnormality or the like represented by a data alarm has occurred in the measurement results of the two types of photometers. The priority output determination unit 59 determines, for the measurement results of the two types of photometers, the measurement result to be output preferentially, based on the predetermined determination and the determination of the priority output setting. The priority output alarm determination unit 60 determines, for example, a data alarm to be output with priority among the two types of data alarms attached to the two types of measurement results.

[Characteristics of photometer]
FIG. 3 shows the characteristics of the absorptiometer 44 and the scattered light clock 45 which are two types of photometers used in the first embodiment. The two types of photometers differ in the characteristics of the quantitative range as shown in FIG. In the graph of FIG. 3, the abscissa represents the theoretical value (unit [U / mL]) and the ordinate represents the measured value of each photometer (unit [U / mL]) with respect to the concentration of the target component substance of the target sample. The area of the broken line indicates the quantitative range of the spectrophotometer 44, which is a type 1 photometer. An area of a dashed dotted line indicates a quantitative range of the scattering photometer 45 which is the second type photometer. A range 301 indicates the normal output range of the quantitative range of the absorptiometer 44. The normal output range indicates, in other words, a range in which measurement and quantification can be suitably performed. The range 302 shows the normal output range of the quantitative range of the scatterometer 45. The range 303 indicates the overlapping range in the two types of

ranges

301 and 302. The range 303 is basically a range in which measurement results of any type of photometer may be used. In the analysis control unit 50, a suitable quantitative range for each photometer is set in advance for output control. That is, the respective ranges corresponding to the range 301, the range 302, the range 303, and the like (at least an upper limit value or a lower limit value defining the range) are set.

The range 301 of the absorptiometer 44 generally has a narrow width (a range of measured values relative to the theoretical value) centered on the reference straight line 300, and has a linear characteristic. In the range where the value is smaller than the range 301, the shape has a width that extends wider than the reference straight line 300, and the characteristic is a large error. The range 302 of the scattering photometer 45 generally has a narrow width centered on the reference straight line 300 and has a linear characteristic. In the range where the value is larger than the range 302, the shape has a width that spreads in the region below the reference straight line 300, and the characteristic is a large error.

When two types of measurement results are obtained by simultaneous analysis, the analysis control unit 50 selects the measurement result to be output based on the determination of the above-mentioned characteristic (corresponding range) as follows. This determination is included in the definition of the correspondence table described later. With regard to the concentration of the target component substance, for the relatively high concentration range (for example, the range of about 10 U / mL or more), as shown by the range 301, the quantification of the absorptiometer 44 is more accurate and suitable. . Therefore, the measurement result of the absorptiometer 44 is selected as an output. Also, conversely, for a relatively low concentration range (for example, a range of about 5 U / mL or less), as shown by the range 302, the quantification of the scattering photometer 45 is more accurate and preferable. Therefore, the measurement result of the scattering photometer 45 is selected as an output.

Furthermore, in a relatively medium concentration range (for example, a range of about 5 U / mL to about 10 U / mL) corresponding to the range 303, any of the two types of measurement results can be basically used. is there. In the case of this range, the measurement result of one of the photometers of one type is selected as an output according to, for example, a priority output setting described later. Each inspection item has a priority output setting.

[Priority output setting]
The priority output setting is a setting as to which of the two photometers of the absorptiometer 44 and the scatterometer 45 to use and output the measurement result and the data alarm preferentially. The automatic analyzer 1 has a priority output setting function, and the operator sets in advance priority output settings as default settings on the implementation, and stores corresponding priority output setting information. As the priority output setting information, which type of photometer is to be prioritized is set by a value of a predetermined format such as priority. The priority output setting information can be set in advance, for example, through the input unit 72. In the automatic analyzer 1, the on / off state of the priority output setting function is also set, and the state can also be variably set by the operator or the user. If you want to disable the priority output setting function, it is set to the off state. As described later, in the ON state, the priority output determination is performed based on the priority output setting information, and is not performed in the OFF state.

[Absorption / scattering simultaneous analysis function]
The automatic analyzer 1 has a simultaneous analysis function which is a function of performing measurement and analysis simultaneously using the two types of photometers with respect to the subject sample 2 based on the characteristics of the two types of photometers. When receiving the simultaneous analysis request for the target component substance of the sample 2, the automatic analyzer 1 performs simultaneous absorption and scattering analysis. In this function, measurement by the absorptiometer 44 and measurement by the scattering photometer 45 are performed for the target component substance of the same one inspection item of the same one sample 2 of interest, and two types of measurement results are obtained. At that time, the automatic analyzer 1 measures the reaction process of the reaction liquid 3 of the reaction container 25 of the sample 2 of interest substantially simultaneously at the same time using two types of photometers. In addition, since each measurement is performed at two types of measurement positions on the reaction disk 20, it has a predetermined time difference. The reaction process is a continuous measurement process including measurement at predetermined time points on the time axis at predetermined times at which the reaction container 25 is stopped at the measurement position of the photometer.

The automatic analyzer 1 selects a suitable measurement result based on the above-mentioned characteristics from the two types of measurement results in the simultaneous analysis. In the case where the automatic analyzer 1 falls within a relatively high concentration range (for example, the range excluding the range 301 to the range 303), the automatic analyzer 1 selects the measurement result of the absorptiometer 44 and performs the absorbance analysis. When the automatic analyzer 1 falls within a relatively low concentration range (for example, the range excluding the range 302 and the range 303), the automatic analyzer 1 selects the measurement result of the scattering photometer 45 and performs the scattered light analysis. This enables accurate measurement and analysis in a wide concentration range including high concentration and low concentration.

[Auto retest function]
The automatic analyzer 1 has an automatic retesting function which is a function of controlling to automatically retest according to a predetermined judgment when an abnormality or the like at the time of measurement is detected. In the first embodiment, the automatic retesting function is a function controlled in association with the data alarm function and the output control function. The output control function includes a function of selecting automatic reinspection information for the automatic reinspection function.

As an abnormality at the time of measurement, for example, in the case of a minor abnormality such as a sample concentration abnormality, an appropriate result can be obtained by performing remeasurement after measures such as dilution or reduction of the amount of sample 2 It is presumed that the possibility of being obtained is high. Therefore, when an abnormality or the like at the time of measurement is detected, the automatic analyzer 1 automatically outputs a part of the output according to the necessity of automatic retest and the remeasurement condition when necessary according to the combination of corresponding data alarms. Select as retest information. Then, the automatic analyzer 1 automatically controls the remeasurement according to the automatic reinspection information by the automatic reinspection function, and outputs the result of the reinspection.

When the automatic analyzer 1 performs the automatic retest, the automatic analyzer 1 collects a new sample 2 from the sample cup 15 in which the target sample 2 is stored, according to the automatic retest request information and the automatic retest information. Reprocess including dispensing etc. to be stored. The automatic analyzer 1 remeasures the reaction container 25 using a photometer of the selected type. When a data alarm is further appended to the result of the automatic retest, the output selection corresponding to the combination of the data alarm may be applied in the same manner or may not be applied.

[Data alarm function]
The automatic analyzer 1 has a data alarm function which is a function of appending a data alarm representing a detected abnormality or the like to the measurement result of the photometer. Even in the case of simultaneous analysis, the automatic analyzer 1 appends each data alarm to each measurement result of the two types of photometers according to detection of abnormality or the like. In particular, when there is an abnormality or the like in the measurement of the absorptiometer 44, the analysis unit 52 appends a first data alarm indicating the abnormality or the like to the first measurement result of the absorptiometer 44. Further, when there is an abnormality or the like at the time of measurement of the scattering photometer 45, the analysis unit 52 appends a second data alarm indicating the abnormality or the like to the second measurement result of the scattering photometer 45. Analysis data including the measurement result to which the data alarm is added is stored in the data storage unit 55.

[Output control function]
In the case where there is an abnormality or the like at the time of the measurement, a data alarm may be added to the measurement results of all (both) of the plurality (two types) of photometers. In that case, the automatic analyzer 1 has an output control function which is a function of selecting a measurement result to be output, a data alarm or the like according to a combination of data alarms. Further, this output control function includes a function of controlling an automatic retesting function, and includes a function of selecting automatic retest information to be output.

[Example of abnormalities during measurement]
Examples of abnormalities or errors that may occur in an automatic analyzer include: Examples of mechanical abnormalities include insufficient sample amount, insufficient reagent amount, dispensing error due to clogging of the flow path of fibrin contained in the sample 2, and abnormality in the components of the sample 2. As an example of the abnormality of the component of the sample 2, the case where the density | concentration of the sample 2 becomes out of the quantitative range of a photometer as sample concentration abnormality is mentioned. That is, there are cases where the concentration of the sample 2 is too high or too low compared to the quantitative range of the photometer. In addition, cases such as red color change of the sample 2 due to elution of blood cell component, and occurrence of turbidity of the sample 2 observed in dyslipidemic patients may be mentioned.

Data alarm
FIG. 4 shows, in the form of a table, classification definitions of a plurality of types of data alarms that can be output in response to an abnormality, an error or the like that may occur in the automatic analyzer 1. First, various abnormalities and data alarms will be described. Generally, in an automatic analyzer, there are two major technical means for alerting a user based on an abnormality, an error or the like that occurs during measurement and analysis.

The first means is a technique of adding a data alarm to the measurement result and outputting it. In this technology, identification information indicating whether the target component substance of the test item present in one or more test items for each sample is normal or abnormal, and in the case of an abnormality, the type indicating the type of the abnormality etc. The following information is attached as a data alarm. Examples of the information indicating the type of abnormality or the like include an identification code, a mark, an explanatory note, and the like.

When the information of the measurement result with the data alarm is output from the automatic analyzer, the user can recognize the type of abnormality or the like by checking the information on the display screen and confirming the information. Then, the user performs handling work and the like according to the abnormality or the like represented by the data alarm. For example, the user performs the handling operation according to the identification code of the data alarm, the operation manual of the automatic analyzer (it may be a guide on a display screen instead of paper) or the like. The coping operation is an operation or an operation for improving the state such as an abnormality of the automatic analyzer so as to return to the normal state and making it possible to re-examine the state.

The second means is a technology for outputting a system alarm. In this technology, an alarm (for example, voice output) is issued to the user as a system alarm, for example, an abnormality related to the entire automatic analyzer such as a temperature abnormality or an abnormality of a mechanism. The system alarm can also be displayed on the screen as a data alarm added with system alarm identification information as one of the data alarms.

The automatic analyzer 1 according to the first embodiment has a data alarm function corresponding to at least the first means. The automatic analyzer 1 has, as shown in FIG. 4, a plurality of types of data alarms that are predefined according to the type of abnormality or the like. In the first embodiment, a plurality of types of data alarms are roughly divided into three groups and levels as described below. In the table of FIG. 4, (A) is a high level and first group data alarm, (B) is a middle level and second group data alarm, and (C) is a low level and third group data alarm Indicates Note that high, middle and low are relative ones.

(A) First group and high level: In the first group and high level, reexamination is necessary to obtain accurate measurement results because there are abnormalities etc. For that purpose, the condition has been improved by the user It corresponds to the case where the re-examination can not be performed unless it is later The improvement of the state includes the improvement of the sample 2 and the reagent 4, that is, the improvement of the reaction liquid 3 of the reaction container 25, and the improvement of the state of mechanisms such as the dispensing mechanism and the washing mechanism. The improvement of the state means, for example, changing to a state in which the amount of sample 2 is reduced when the amount of sample of the reaction liquid 3 in the reaction container 25 is large, or changing to a state in which the amount of sample 2 is increased when the amount of sample is small. Etc. In such a case, the automatic analyzer 1 outputs a high-level data alarm as output control, and does not immediately perform automatic re-examination, and urges coping operation and operation including user's state improvement. . The automatic analysis device 1 causes the automatic retest to be performed after the state is improved.

(B) Second group and middle level: The second group and middle level require re-examination because they are abnormal, etc., and therefore re-examination is possible without requiring user operation. Corresponds to In this case, it corresponds to the case where it can be inferred that a good measurement result can be obtained by the retesting in which the remeasurement conditions are controlled. In this case, as the re-measurement condition, for example, the automatic analyzer 1 performs the same condition as the previous measurement (that is, at the time of measurement at which an abnormality or the like is detected) Conditions In such a case, the automatic analyzer 1 outputs a medium-level data alarm and tries to obtain a good measurement result by performing re-measurement under the re-measurement condition.

(C) Third group and low level: The third group and low level correspond to the case where remeasurement is not necessary in the obtained measurement results, and the measurement results can be handled as a reference value and output is possible. In this case, the automatic analyzer 1 outputs a low level data alarm.

The above-mentioned data alarm of each group and level is further defined as including various data alarms as follows. Each data alarm is attached with an identification code or the like for the purpose of explanation and implementation. An example of the identification code is indicated by "A1", "B1" or the like.

(A) The first group and high level data alarms include, for example, the following five data alarms. FIG. 4A shows the corresponding table part. In each row of the table, “A1” or the like in parentheses indicates the identification code of the data alarm. In this example, it has a sample shortage alarm A1, a reagent shortage alarm A2, a clogging detection alarm A3, a detergent shortage alarm A4, and a photometer abnormality alarm A5.

(1) When the sample shortage alarm A1 is determined by the liquid level detection sensor or the like included in the sample dispensing mechanism 41 that the amount of the sample 2 of the reaction liquid 3 in the sample cup 15 or the reaction container 25 is insufficient. It is a data alarm that occurs.

(2) When the reagent shortage alarm A2 determines that the amount of the reagent 4 of the reaction liquid 3 in the reagent bottle 35 or the reaction container 25 is insufficient by the liquid level detection sensor or the like provided in the reagent dispensing mechanism 42 It is a data alarm that occurs.

(3) The clogging detection alarm A3 is a pressure sensor or the like provided in the sample dispensing mechanism 41, when it is determined that a blockage has occurred in the flow path, for example, when foreign matter is mixed in the dispensing nozzle at the time of aspiration of the sample 2 It is a data alarm that occurs.

(4) Insufficient detergent alarm A4 is a data alarm generated due to the lack of detergent used for cleaning the dispensing nozzle and the reaction container 25 in the cleaning unit 46.

(5) The photometer abnormality alarm A5 is a data alarm that is generated when an abnormality is detected in the optical system or the substrate (the light source or the light receiving unit described above) of the absorptiometer 44 or the scattering photometer 45.

(B) The second group and middle level data alarms are roughly classified into (B-1) data alarms derived from reaction process abnormalities and (B-2) data alarms derived from sample concentration abnormalities. For example, the following data alarms may be mentioned, for example. The corresponding table part is shown in FIG. 4 (B).

(B-1) Examples of data alarms derived from reaction process abnormalities include cell blank abnormality alarm B1, absorbance difference abnormality alarm B2, scattered light intensity difference abnormality alarm B3, and calculation impossible alarm.

(1) If the cell blank value measured before analysis of the target component substance of the sample 2 deviates from the cell blank value stored in advance in the automatic analyzer 1, or the comparison target is the cell blank abnormality alarm B1 This is a data alarm that occurs when there is a discrepancy with the cell blank value of another reaction vessel. The cell blank value is an optical measurement value in a state where the reaction liquid 3 is not contained in the reaction container 25.

(2) The absorbance difference abnormality alarm B2 indicates that the absorbance difference or the rate of change in absorbance between specific measurement points in the reaction process of the target component substance measured by the absorptiometer 44 satisfies a predetermined threshold set in advance. It is a data alarm that occurs when there is no or when the threshold is exceeded.

(3) The scattered light intensity difference abnormality alarm B3 is configured such that the scattered light intensity difference or the scattered light intensity change rate between specific measurement points in the reaction process of the target component substance measured by the scattering photometer 45 is set in advance. It is a data alarm that occurs when the specified threshold is not met or exceeds the threshold.

Since data alarms derived from these reaction process abnormalities are unlikely to have abnormalities in the mechanism of the automatic analyzer 1, sample 2 and reagent 4 etc., it is possible to cope with cases where automatic retesting is possible without the user performing state improvement work. Do. Therefore, in this case, as the output control, the automatic analyzer 1 causes the automatic retest as the remeasurement condition under the same condition as that of the previous measurement to obtain an accurate measurement result.

(B-2) As alarms derived from sample concentration abnormality, prozone alarm B4, quantitative range upper limit alarm B5, absorbance / scattered light intensity over alarm, quantitative range lower limit alarm B6, repeat upper limit alarm, repeat lower limit alarm, etc. There is.

(1) Prozone Alarm B4 is a data alarm that occurs when the amount of antigen or antibody in sample 2 in the immunoassay is excessive. As a determination method regarding this, there are a known reaction rate ratio method, an antigen / antibody re-addition method, and the like. In the reaction ratio method, the change in absorbance per unit time (or the change in scattered light intensity) and the change in absorbance at the end of the reaction (or change in scattered light intensity) from the reaction process of the target component substance of the test item Calculate the ratio to the amount) and compare it with the preset threshold. In the antigen / antibody re-addition method, an antigen or antibody is additionally added after completion of the reaction, and the change in absorbance or the change in scattered light intensity per unit time immediately after the addition is calculated and compared with the preset threshold value. Do.

(2) Quantitative range upper limit over alarm B5 is one of technical limit over, and is a data alarm that occurs when the upper limit value of the suitable quantitative range for each type of photometer set in advance is exceeded. For example, this data alarm occurs when the concentration of the sample 2 in the reaction solution 3 is too high for the photometric range. For example, in the case of measurement by the absorptiometer 44 in FIG. 3 described above, this data alarm occurs when the concentration of the sample 2 exceeds the upper limit value of the normal output range 301.

(3) Quantitative range lower limit over alarm B6 is one of technical limit over, and is a data alarm that occurs when the lower limit value of the suitable quantitative range for each type of photometer set in advance is exceeded. For example, this data alarm occurs when the concentration of the sample 2 in the reaction solution 3 is too low relative to the quantitative range of the photometer. For example, in the case of measurement by the absorptiometer 44 in FIG. 3 described above, this data alarm occurs when the concentration of the sample 2 falls below the lower limit value of the normal output range 301.

Usually, the target component substance is excessively contained in the sample 2 in which the abnormality corresponding to the pro zone alarm B4 has occurred, and the concentration is high. Therefore, the quantitative range upper limit over alarm B5 is also generated simultaneously. The pro zone alarm B4 occurs when the amount of the target component substance is more than that of the quantitative range upper limit alarm B5. Therefore, when these two data alarms occur simultaneously, the automatic analyzer 1 selects and outputs only the pro zone alarm B4 as output control. These data alarms correspond to the case where automatic retesting is possible because there is no abnormality in the mechanism of the automatic analyzer 1, the sample 2, the reagent 4 and the like.

When the pro zone alarm B4 or the quantitative range upper limit over alarm B5 occurs, it indicates that the concentration of the target component substance in the sample 2 is too high. Therefore, in this case, the automatic analyzer 1 causes the automatic retest to be performed under the condition that the amount of the sample of the reaction liquid 3 is reduced (or the state where the sample 2 is diluted with the reagent 4) as remeasurement conditions. In addition, when the quantitative range lower limit over alarm B6 occurs, it indicates that the concentration of the target component substance in the sample 2 is too low. Therefore, in this case, the automatic analyzer 1 causes the automatic retest to be performed with the amount of the sample of the reaction liquid 3 increased as the remeasurement condition.

(C) Examples of the third group and low level data alarms include the following two. FIG. 4C shows the corresponding table portion. In this example, it has a serum information alarm C1, a reagent expiration alarm C2, and a sample carryover.

(1) Serum information alarm C1 is a data alarm that occurs when a coexistent substance that affects the analysis of the target component substance is mixed in the sample 2 such as blood. The coexisting substances include lipids, hemoglobin, bilirubin and the like. The samples 2 (also referred to as abnormal samples) in which the coexisting substances are mixed are called milk beads, hemolysis, and yellow, respectively. Hemolysis (also referred to as red change) and yellow cause a color change of the sample 2 and therefore, the absorptiometer 44 is largely affected. Since the milk bottle causes a change in the turbidity of the sample 2, the influence on the scattering photometer 45 is large. Serum information is information on coexistent substances as described above. Serum information is usually measured by measuring the absorbance of the sample 2 itself using the light of the wavelength corresponding to each coexisting substance using the reagent 4 which does not react with the sample 2 separately from the analysis of the target component substance of the test item It is judged. Each measured absorbance is compared with each preset threshold value, and a serum information alarm C1 is added to one that exceeds the threshold value.

(2) Reagent Expiration Date Alarm C2 is a data alarm that occurs when the expiration date of the reagent 4 registered in the automatic analyzer 1 has expired.

When these low level data alarms are output, the measurement itself ends normally and the measurement results are obtained. Therefore, the automatic analyzer 1 handles and outputs the measurement result as a reference value as output control. In this case, the condition is not improved unless the sample 2 or the reagent 4 is replaced. Therefore, the automatic analyzer 1 makes automatic retest unnecessary and does not perform it.

In the output control function of the automatic analyzer 1, based on the detection of an abnormality, the definition of the data alarm, and the predetermined determination by the analysis control unit 50 (in particular, the analysis unit 52) for each measurement of two types of photometers. A selected basically one data alarm is attached to the measurement result. Information in which a data alarm is added to the measurement result is temporarily stored in the data storage unit 55. Each unit such as the simultaneous analysis determination unit 56 performs output control with reference to the information in the data storage unit 55.

Note that, depending on the type of abnormality or the like, a plurality of data alarms may be candidates for appendage regarding the measurement results of one type of photometer. In that case, the automatic analyzer 1 selects and appends one data alarm based on the pre-setting and the predetermined judgment. This setting is a design matter of the data alarm function. For example, as the definition of the data alarm, the importance or the priority is set between a plurality of types of data alarms (corresponding abnormalities or the like). Although not shown in FIG. 4, for example, a priority number is set for each data alarm. The analysis unit 52 selects the data alarm with the highest priority among the plurality of candidate data alarms. In addition, as an automatic analyzer of a modification, it does not have the above priority setting, and a plurality of data alarms may be added to one measurement result.

Although the three levels of data alarms and corresponding abnormalities have been described above with some specific examples, the present invention is not limited thereto, and the same applies to other types of abnormalities and data alarms. is there. The table of FIG. 4 also describes examples of other types of data alarms not having identification codes, and although they are not used for output control in the embodiment, they can be similarly used in other embodiments. .

[Analysis process (1)]
Next, an output control process according to a combination of data alarms related to the output control function of the automatic analyzer 1 will be described. First, an analysis process performed by the measurement unit 51, the analysis unit 52, and the control unit 53 of the analysis control unit 50 in FIG. 2 will be described as a first step. The analysis control unit 50 performs analysis processing of the target sample 2 for which the analysis request has been received. At this time, the control unit 53 determines whether the simultaneous analysis request is set as the analysis request. When the simultaneous analysis request is set, the control unit 53 causes the measurement unit 51 and the analysis unit 52 to select the target sample 2 based on the respective measurement values (the aforementioned signals) obtained from the two types of photometers. Perform each analytical process (Absorptiometry and Scattered Light Analysis) of The control unit 53 has not set a request for simultaneous analysis, but has set a request for analysis by one of two types of photometers ("absorbance analysis" or "scattered light analysis" as "single analysis") In this case, the measurement unit 51 and the analysis unit 52 perform analysis processing of the target specimen 2 based on the measurement value of the corresponding one photometer.

The measuring unit 51 measures the light intensity / light intensity of the target specimen 2 based on the measured value or the calculated value included in the signal from the photometer for each type of photometer. Based on the measurement value from the absorptiometer 44, the measurement unit 51 obtains the light amount / light intensity of the transmitted light by the reaction liquid 3 of the reaction container 25 in which the measurement value is obtained. In addition, the measurement unit 51 obtains the light amount / light intensity of the scattered light by the reaction liquid 3 of the reaction container 25 in which the measurement value is obtained based on the measurement value from the scattering photometer 45. For example, the measurement unit 51 calculates the light intensity based on the light amount of the transmitted light or the scattered light which is the measurement value. Then, the measurement unit 51 stores the data of the light intensity as measurement data in which the information of the reaction container 25 of the target to which the target sample 2 is dispensed is associated or the analysis request information of the sample 2. Store in section 55. In addition, in the measurement part 51, you may measure and calculate not only light intensity but another parameter. In addition, the measurement data includes information on the reaction process measured by the photometer (that is, a measured value at each measurement point, etc.). The analysis request information includes information such as the target sample 2 and the reagent 4.

The analysis unit 52 analyzes the target component substance of the sample 2 in the target reaction liquid 3 with reference to the information of the measurement data by the measurement unit 51, and at least one of the concentration or the component amount of the target component substance Determine the amount "). The analysis unit 52 reads out the light amount / light intensity of the transmitted light or the light amount / light intensity of the scattered light in the measurement data, and obtains the concentration of the target component substance. For example, the analysis unit 52 refers to the light intensity and refers to the information of the calibration curve, and calculates the concentration of the target component substance from the light intensity. At this time, the analysis unit 52 converts the light intensity into a concentration using a calibration curve corresponding to the reagent 4 used for the reaction liquid 3 which has been prepared in advance. When the absorptiometer 44 is used, the analysis unit 52 converts the transmitted light intensity into the concentration of the target component substance using a calibration curve for the absorptiometer 44. When the scattering photometer 45 is used, the analysis unit 52 converts the scattered light intensity into the concentration of the target component substance using the calibration curve for the scattering photometer 45.

The calibration curve represents the relationship between the concentration of each target component substance determined using a sample such as a standard substance containing a target component substance of a known concentration, and the light amount / light intensity of transmitted light or scattered light. In advance, calibration curve data of the reagent 4 of each reagent bottle 35 of the reagent disc 30 is stored in the data storage unit 55.

Then, the analysis unit 52 stores the information of the concentration obtained by the analysis in the data storage unit 55 as analysis data associated with the reaction container 25 of the target sample 2 or the information of the analysis request. In the embodiment, the concentration of the target component substance is mainly dealt with as the measurement result. The measurement result can be paraphrased as an analysis result, an analysis result, or the like.

In addition, when performing the analysis, the analysis unit 52 measures the target sample 2 based on the reaction process measured by each photometer, the analyzed concentration, the analysis parameter information set in advance, and the like. It is determined whether an error or an error has occurred. The example of the abnormality etc. is as above-mentioned. If the analysis unit 52 determines that an abnormality or the like at the time of measurement has occurred, a data alarm corresponding to the type of abnormality or the like is added to the measurement result including the concentration corresponding to the type of photometer; They are stored in the data storage unit 55 as analysis data. When appending the data alarm, the analysis unit 52 appends the data alarm selected according to the classification definition as shown in FIG. 4 and the predetermined determination.

The control unit 53 monitors the occurrence of an abnormality, an error, or the like of the sample disc 10, the sample dispensing mechanism 41, and portions such as each mechanism including the respective photometers, while analyzing the target sample 2. And it is judged. When an abnormality or the like of the mechanism is detected by the control unit 52, control result information including information indicating the abnormality or the like is stored in the data storage unit 55. The analysis unit 52 refers to the control result information from the data storage unit 55 in addition to the measurement data. The analysis unit 52 determines, based on the measurement data and the control result information, the presence or absence of an abnormality or the like at the time of measurement, and the type of the abnormality or the like.

As described above, as the first step, data including the measurement result is stored in the data storage unit 55 as an analysis result by the measurement unit 51, the analysis unit 52, and the control unit 53. When there is an abnormality or the like at the time of measurement, data in which a data alarm is added to the measurement result is obtained. In the case of simultaneous analysis, respective data are obtained for each type of photometer. Then, as a second step, the analysis control unit 50 performs output control processing of the analysis result of the target sample 2 as follows. The analysis control unit 50 performs the processing of the second stage by the simultaneous analysis determination unit 56, the automatic retest determination unit 57, the measurement error check unit 58, the priority output determination unit 59, the priority output error determination unit 60, and the like. The analysis control unit 50 outputs the analysis result on the display screen of the output unit 71 using them.

[Analytical processing (2)]
Next, output control processing in the second stage will be described with reference to FIG. In the case of simultaneous analysis, the analysis control unit 50 outputs analysis data including the measurement results of each of the two types of photometers to the simultaneous analysis determination unit 56 via the data storage unit 55. The simultaneous analysis determination unit 56 refers to the analysis data from the data storage unit 55. Further, the analysis control unit 50 causes the automatic retest determination unit 57, the measurement abnormality check unit 58, the priority output determination unit 59, the priority output error determination unit 60, and the like to perform processing as necessary.

When the analysis control unit 50 outputs the result of simultaneous analysis to the user on the display screen of the output unit 71, the simultaneous analysis determination unit 56 determines the target component based on the above-mentioned characteristics from the two types of measurement results. Depending on the concentration of the substance, etc., select one suitable measurement result. Furthermore, when one or more data alarms are added to the two types of measurement results, the analysis control unit 50 outputs the measurement results, the data alarms, and the like, according to the combination of the data alarms, as described below. And perform output control processing to select automatic retest information.

[Correspondence table]
FIG. 5 to FIG. 8 show a correspondence table in which correspondence between combinations of a plurality of data alarms and outputs used for output control is defined in the automatic analyzer 1. In particular, the correspondence table for the above-mentioned mid-level data alarm is shown. The analysis control unit 50 and the output control function perform output control processing according to the definition of such a correspondence table. In the first embodiment, this output control process is implemented as a software program process as in the process flow described later. Note that this correspondence table may be held as a table or the like on mounting (that is, determination etc. may be performed with reference to the table), or the table or the like may be implemented as a processing flow. It may be omitted.

FIG. 5 shows, as a first part of the correspondence table, a first example of the correspondence between the combination of the above-mentioned middle level data alarms and the output. FIG. 5A particularly shows the combination of data alarms derived from (B-1) reaction process abnormality. The first column “absorptivity” of the correspondence table indicates a first data alarm regarding the first measurement result using the absorptiometer 44. The second column "Scattering" shows a second data alarm on the second measurement using scatterometer 45. That is, the set of the first column and the second column indicates a combination of two types of data alarms. The third column “output” of the correspondence table indicates the selection regarding the measurement result as the output content selected in the case of the combination of the first column and the second column. The fourth column “retest” in the correspondence table indicates the necessity (presence or absence) of automatic retest by the selected automatic retest function. The fifth column “condition” of the correspondence table indicates an automatic re-examination condition (that is, a re-measurement condition etc.) in the case where one of the selected automatic re-examination requests is made.

In FIG. 5A, as values of the first column “absorptivity” and the second column “scattering”, according to FIG. "Absorbance difference abnormality" (B2) / "scattered light intensity difference abnormality" (B3); "Cell blank error" (B1); It has "impossible to calculate". There is a combination of 3 × 3 = 9 as a combination of these three types of values. Here, although the absorbance difference abnormality alarm B2 and the scattered light intensity difference abnormality alarm B3 are put together into one, a combination of them may be considered. The values of the third column “output”, the fourth column “retest”, and the fifth column “condition” are defined for each row of each combination. There are three types of values of “output” in the third column, “absorptivity” (value 1), “scatter” (value 2), and “priority” (value 3). "Absorbance" (value 1) represents the selection of the first measurement result and the first data alarm towards the absorptiometer 44. "Scattering" (value 2) represents the selection of the second measurement result and the second data alarm towards the scatterometer 45. "Priority" (value 3) represents the selection of one of two types of measurement results and data alarms according to the determination of the priority output settings. There are two types of values of "re-examined" (value 1) and "absent" (value 2) as the values of the fourth column "retest". "Present" (value 1) indicates the necessity (presence) of automatic retest. "None" (value 2) represents the necessity (none) of automatic re-examination. There are three types of values of "condition" in the fifth column, "same" (value 1), "decrease" (value 2), and "increase" (value 3). “Same” (value 1) represents the same conditions (remeasurement conditions etc.) as in the previous measurement. “Loss weight” (value 2) represents changing to a condition in which the sample 2 is reduced with respect to the condition at the time of the previous measurement. The term "increase" (value 3) represents changing to a condition in which the sample 2 is reduced with respect to the condition at the time of the previous measurement.

As an example, in the combination (1-1) of the first row, "B2 / B3"-"B2 / B3" is a combination of "absorbance"-"scatter" data alarm, and "output" = "priority" ( Value 3), “retest” = “presence” (1), “condition” = “same” (value 1). In this case, the analysis control unit 50 selects and outputs the measurement result of one of the photometers and the data alarm (B2 / B3) according to the determination of the priority output setting, and carries out the automatic retest information to make an automatic retest request under the same conditions as the previous time. I assume. The same output is obtained by combining other lines.

Similarly, (B) of FIG. 5 particularly shows a combination of data alarms derived from (B-2) sample concentration abnormality. In FIG. 5 (B), as values of the first column “absorptivity” and the second column “scattering”, according to FIG. “Absorbance and scattered light intensity over”, and 2. "Pro-zone" (B4); "Over the upper limit of quantitative range" (B5); "Over the lower limit of determination range" (B6). There is a combination of 4 × 4 = 16 as a combination of these four types of values.

As an example, lines 4 to 8 are four combinations in which the data alarm of "absorptivity" is pro zone alarm B4, and as the output selection, "output" = "absorptivity" (value 1), "retest" “=” Present ”(value 1),“ condition ”=“ loss ”(value 2). In these cases, the analysis control unit 50 selects and outputs the first measurement result and the second data alarm (B4) of the absorptiometer 44, and performs an automatic retesting request to perform an automatic retest request under the conditions reduced from the previous conditions. It is information. The 9th to 12th lines show the case of four combinations in which the "light absorption" data alarm is the quantitative range upper limit alarm B5, and the output selection is the same. The 13th line to the 16th line are for the case of four combinations in which the “light absorption” data alarm is a quantitative range lower limit over alarm B5. In the 13th, 14th, and 15th rows, “output” = “absorptive” (value 1), “retest” = “presence” (value 1), “condition” = “increase” as output selection. (Value 3). In these cases, the analysis control unit 50 selects and outputs the first measurement result of the absorptiometer 44 and the first data alarm (B6), and performs an automatic retesting request to perform an automatic retest request under the conditions increased with respect to the previous conditions. It is information. In the combination of the 16th line, “output” = “scatter” (value 2), “retest” = “presence” (value 1), and “condition” = “increase” (value 3) as the output selection. In this case, the analysis control unit 50 selects and outputs the second measurement result of the scattering photometer 45 and the second data alarm (B6), and performs automatic retest information on which an automatic retest request is performed under the condition of increasing the previous condition. I assume.

FIG. 6 shows, as the second part of the correspondence table, a combination of (B-1) reaction process abnormality and (B-2) sample concentration abnormality in a medium level data alarm. Here, as the values of the first column “absorptivity” and the second column “scattering”, the aforementioned “B2 / B3”, “B1”, “impossible to calculate”, “absorbance / scattered light intensity difference over”, “B4” There are seven types of values, "B5" and "B6".

As an example, lines 1 to 4 show that the data alarm for "absorptive light" is (B-1) "B2 / B3" of the reaction process abnormalities and the data alarm for "scattering" is (B-2) This is the case of four combinations where the sample concentration is abnormal. In the first to third lines, “output” = “absorptivity” (value 1), “retest” = “presence” (value 1), and “condition” = “same” (value 1) as output selection. . In line 4, as the output selection, “output” = “scatter” (value 2), “retest” = “presence” (1), “condition” = “increase” (value 3). The fifth to eighth lines indicate that the data alarm for "absorptive light" is "B1" of (B-1) reaction process abnormality, and the data alarm for "scattering" is (B-2) sample concentration abnormality , In the case of four combinations. The output selection is similar to the first to fourth lines.

Also, for example, in lines 16 to 18, the data alarm of "absorptivity" is (B-2) prozone alarm B4 of the sample concentration abnormalities and the data alarm of "scatter" is (B-1) It is a case of three combinations which are reaction process abnormalities. In lines 16 to 18, “output” = “absorbance” (value 1), “retest” = “presence” (value 1), and “condition” = “loss” (value 2) as output selection. . Also, for example, in the 19th line through the 21st line, the “light absorption” data alarm is (B-2) the quantitative range upper limit alarm B5 of the sample concentration abnormalities, and the “scattering” data alarm is (B− 1) It is a case of three combinations which are reaction process abnormalities. In lines 19 to 21, as output selection, “output” = “absorptive light” (value 1), “retest” = “presence” (value 1), “condition” = “loss” (value 2) . Also, for example, in lines 22 to 24, the data alarm of “absorptive light” is (B-2) quantitative range lower limit alarm B6 of the sample concentration abnormality, and the data alarm of “scattered” is (B− 1) It is a case of three combinations which are reaction process abnormalities. In lines 22 to 24, “output” = “absorbance” (value 1), “retest” = “presence” (value 1), “condition” = “increase” (value 3) as the output selection. .

FIG. 7 shows, as a third part of the correspondence table, a portion of a combination of a medium level (B-1) reaction process abnormality data alarm and a low level data alarm. Here, as the values of the first column “absorptive light” and the second column “scattering”, the aforementioned “B2 / B3”, “B1”, “calculation impossible”, “serum information (C1)”, “specimen carryover” There are six types of values, "Reagent Expired (C2)".

For example, lines 1 to 4 show that the data alarm for "absorptive light" is (B-1) "B2 / B3" of reaction process abnormality, and the data alarm for "scattering" is 3 types of low level It is the case of three combinations. In the first to third lines, “output” = “scatter” (value 2), “retest” = “absent” (value 2), “condition” = “-” (no value) as output selection. . In these cases, the analysis control unit 50 selects and outputs the second measurement result of the scattering photometer 45 and the second data alarm (low level), and does not perform an automatic retest request. Similarly, the fourth to sixth lines are the cases of three combinations in which the "light absorption" data alarm is "B4" and the "scatter" data alarm is three types of low level. Also in these cases, the same output selection is made.

Lines 10 to 12 show that the “light absorption” data alarm is a low level serum information alarm (C1 and “scatter” data alarm is three types of reaction process abnormality (B-1), In the 10th to 12th lines, “output” = “absorptive” (value 1), “retest” = “absent” (value 2), “condition” = “-” as the output selection. In these cases, the analysis control unit 50 selects and outputs the first measurement result and the first data alarm (low level) of the absorptiometer 44, and does not request an automatic retest. In lines 16 to 18, there are three combinations of the “absorptive” data alarm being the reagent expiration alarm C2 and the “scattering” data alarm being three types of (B-1) reaction process abnormality. In these cases, similar output selection is It has become.

FIG. 8 shows, as a fourth part of the correspondence table, a combination of a medium level (B-2) sample concentration abnormality data alarm and a low level data alarm. Here, as the values of the first column "absorptivity" and the second column "scattering", the above-mentioned "absorbance · scattered light intensity over", "B4", "B5", "B6", "serum information (C1)" , "Specimen carryover", and "reagent expired (C2)".

As an example, lines 1 to 4 show that the “absorbance” data alarm is (B-2) “absorbance / scattered light intensity over” among the sample concentration abnormalities, and the “scatter” data alarm is at a low level. In the case of three combinations of three. In the first to third lines, “output” = “absorptive light” (value 1), “retest” = “presence” (value 1), “condition” = “loss” (value 2) as output selection. . Similarly, the fourth to sixth lines are the cases of three combinations in which the "light absorption" data alarm is "B4" and the "scatter" data alarm is three types of low level. Also in these cases, the same output selection is made. Similarly, the seventh to ninth lines are cases of three combinations in which the “absorbance” data alarm is “B5” and the “scatter” data alarm is three types of low level. Also in these cases, the same output selection is made. Similarly, the 10th to 12th lines are the cases of three combinations in which the “absorptive” data alarm is “B6” and the “scattering” data alarm is three types of low level. In these cases, “output” = “scatter” (value 2), “retest” = “absent” (value 2), and “condition” = “-” as the output selection.

The 13th to 16th lines show four combinations of “absorptive” data alarm is low level serum information alarm C1 and “scattered” data alarm is (B-2) four kinds of sample concentration abnormalities. In the case of In lines 13 to 15, as output selection, “output” = “absorptivity” (value 1), “retest” = “absent” (value 2), and “condition” = “−”. In the sixteenth line, “output” = “scatter” (value 2), “retest” = “presence” (value 1), and “condition” = “increase” (value 3) as the output selection. Similarly, the combination of lines 17 to 20 has the same output selection. Similarly, in the combination of the 21st line to the 24th line, the "absorbance" data alarm is the case of the low level reagent expiration alarm C2, and the same output selection is made.

Processing flow
Next, a flow of output control processing by the analysis control unit 50 of the automatic analyzer 1 will be described with reference to FIGS. 9 to 14.

[(1) Output control processing]
FIG. 9 shows the flow of the first process of the analysis control unit 50. The first process shows an output control process of selecting a measurement result and a data alarm to be output using one or both of two types of photometers. This flow has steps S201 to S210. The steps will be described in the following order. Note that a plurality of processing flows after FIG. 9 are illustrated and described as a plurality of flow diagrams for the sake of explanation. These processing flows are logically connected between the steps, and can be regarded as one processing flow as a whole. That is, it is possible to realize also as one program processing as a whole by the CPU or the like of the analysis control unit 50.

(S201) The simultaneous analysis determination unit 56 confirms whether or not the format of the analysis request for the target sample 2 is a simultaneous analysis request. If it is a simultaneous analysis request (Y), the process proceeds to S204, and if it is not a simultaneous analysis request (N), the process proceeds to S202. The case of not being a simultaneous analysis request corresponds to the setting of a single analysis request (absorptiometric analysis request or a scattered light analysis request) by one of the absorptiometer 44 and the scattering photometer 45. There may be other forms of analysis request. For example, there may be a “absorptive two-item simultaneous analysis” request. “Absorbent two-item simultaneous analysis” is to measure and analyze two target component substances simultaneously for the reaction liquid 3 in the reaction container 25 of the sample 2 of the same target using only the absorptiometer 44.

(S202) In the case of a single analysis request, the simultaneous analysis determination unit 56 causes the output unit 71 to output all the data (including the measurement result and the data alarm) measured by one requested photometer. As a result of the single analysis, the display screen of the output unit 71 displays the concentration which is the measurement result, and the data alarm added when there is an abnormality or the like at the time of measurement.

(S203) Furthermore, the automatic retest determination unit 57 determines, for the measurement result of the single analysis, necessity or the like of the automatic retest based on an abnormality or the like during measurement. The automatic reexamination determination unit 57 determines that the automatic reexamination is unnecessary when the data alarm is not added to the measurement result or when the high level or low level data alarm is added. If unnecessary (not), the automatic retest request is not performed, and this flow ends. When the middle level data alarm is added to the measurement result, the automatic reexamination determination unit 57 determines that the automatic reexamination is necessary, and in that case (necessary), the process proceeds to S210.

(S210) The automatic reexamination determination unit 57 makes an automatic reexamination request under the automatic reexamination condition according to the type of the data alarm. That is, the automatic reinspection determination unit 57 stores the automatic reinspection request information including the remeasurement conditions and the like in the data storage unit 55. The automatic reexamination function of the analysis control unit 50 controls the automatic reexamination in accordance with the automatic reexamination request information.

On the other hand, when the simultaneous analysis determination unit 56 requests the simultaneous analysis in S201, the simultaneous analysis determination unit 56 uses the first measurement result using the absorptiometer 44 and the scattering photometer 45 for the target sample 2 for which the request is made. All data including both the second measurement result and the second measurement result are output through the measurement error check unit 58 as follows. All the above data are stored in the data storage unit 55 by the measurement unit 53 and the analysis unit 52 described above.

(S204) The measurement abnormality check unit 58 determines whether a data alarm is added to the first measurement result and the second measurement result which are measurement results of the two types of photometers. That is, the measurement abnormality check unit 58 checks whether or not an abnormality or the like at the time of measurement represented by a data alarm has occurred in each measurement result. As a result of this determination, if there is an abnormality or the like only in the first measurement result (A), the process proceeds to S207, and if there is an abnormality or the like only in the second measurement result (B), the process proceeds to S209. In addition, when there is an abnormality or the like in both of the first measurement result and the second measurement result as a result of the determination (C), the process proceeds to S205 (FIG. 3). In addition, when there is no abnormality or the like in both the first measurement result and the second measurement result as a result of the determination (D), the process proceeds to S206.

(S207) The measurement time abnormality check unit 58 causes the output unit 71 to output all data related to the scattered light analysis, including the second measurement result. Thereby, on the display screen of the output unit 71, as a result of the simultaneous analysis, data having no abnormality or the like including the concentration obtained through the scattering photometer 45 is preferentially output to the user.

(S209) The measurement abnormality check unit 58 causes the output unit 71 to output all the data related to the absorbance analysis, including the first measurement result. Thereby, on the display screen of the output unit 71, data having no abnormality or the like, including the concentration obtained through the absorptiometer 44, is preferentially output to the user.

(S205) The priority output alarm determination unit 60 performs priority output alarm determination processing described later (FIG. 10). In this process, as a summary, which data alarm of the first data alarm attached to the first measurement result and the second data alarm attached to the second measurement result is selected and output preferentially Is a process of determining

(S206) The priority output determination unit 59 performs priority output determination processing on the first measurement result and the second measurement result which are measurement results of the two types of photometers. This process is a process of determining which of the measurement results of the two types of photometers is to be selected and output preferentially. At the time of this determination, the priority output determination unit 59 refers to the data storage unit 55 for priority output setting information set in advance of the analysis request. For example, priority output setting information is set as one of the parameters of analysis request information. The priority output setting information includes, for example, a setting value of priority output order indicating which of the first measurement result and the second measurement result is to be used as the priority output. For example, as a priority output order, a value 1 represents a setting for preferentially outputting the first measurement result (“absorbance priority setting”), and a value 2 represents a setting for preferentially outputting the second measurement result (“scattering priority setting”) . In either priority setting, basically, only the measurement result of one type of photometer is output. The priority output determination unit 59 selects one of the first measurement result and the second measurement result according to the priority output setting information of the analysis request information.

If it is determined in step S206 that the priority output setting function is in the on-state and the "scattering priority setting" is set (A), the process proceeds to step S207, and if the light absorption priority setting is set (B), the process proceeds to step S209. If the priority output setting function is off, that is, if there is no priority output setting between the two photometers (C), the process proceeds to S208.

(S207) The priority output determination unit 59 causes the output unit 71 to output all data including the second measurement result of the scattering photometer 45. As a result, on the display screen of the output unit 71, all the data including the second measurement result and having no abnormality or the like is preferentially output to the user.

(S209) The priority output determination unit 59 causes the output unit 71 to output all data including the first measurement result of the absorptiometer 44. As a result, on the display screen of the output unit 71, all the data including the first measurement result and having no abnormality or the like is preferentially output to the user.

(S208) The priority output determination unit 59 causes the output unit 71 to output all data including both the first measurement result and the second measurement result. As a result, on the display screen of the output unit 71, all data having no abnormality or the like including the measurement results of the two types of photometers are output to the user. After S207, S208, or S209, the present flow ends.

[(2) Priority output alarm determination process]
Next, the contents of the priority output alarm determination process of step S205 of FIG. 9 will be described using FIG. FIG. 10 shows a flow related to data alarm level classification determination processing as the first processing of the priority output alarm determination processing by the priority output alarm determination unit 60 in S205. In this process, the data alarm associated with each measurement result of the two types of photometers is determined based on the above-mentioned classification definition of the group and the level, and the classification is determined. This flow has steps S301 to S305. The steps will be described in the following order.

(S301) The priority output alarm determination unit 60 determines the first data alarm attached to the first measurement result of the absorptiometer 44 and the second data alarm attached to the second measurement result of the scattering photometer 45. Refer to 2 types of data alarms. The priority output alarm determination unit 60 determines whether or not the third group and the high level data alarm are included in one or both of the two types of data alarms. If it is included (Y), the process proceeds to S302, and if it is not included (N), the process proceeds to S303.

(S302) The priority output alarm determination unit 60 executes high-level data alarm processing described later (FIG. 11), and then ends this flow.

(S303) The priority output alarm determination unit 60 determines whether or not the second group and medium level data alarms are included in one or both of the two types of data alarms. If it is included (Y), the process proceeds to S304, and if it is not included (N), the process proceeds to S305.

(S304) The priority output alarm determination unit 60 executes middle-level data alarm processing described later (FIGS. 12 and 13), and then ends the present flow.

(S305) If not included (N) in S303 above, that is, if a third group and low level data alarms are included. In S305, the priority output alarm determination unit 60 executes low level alarm processing described later (FIG. 14).

[(3) High level data alarm processing]
FIG. 11 shows the flow of the high level data alarm process of S302. FIG. 11 has steps S401 to S405. The steps will be described in the following order.

(S401) The priority output alarm determination unit 60 determines whether a high level data alarm is added to both the first measurement result and the second measurement result, in other words, between the first data alarm and the second data alarm. Check if both are high level data alarms. If both are high level (Y), the process proceeds to S402; otherwise (N), the process proceeds to S403.

(S402) The priority output alarm determination unit 60 causes the output unit 71 to output, as an output, high-level data alarms of both the first data alarm and the second data alarm, and ends this flow.

(S403) The priority output alarm determination unit 60 confirms whether one of the first data alarm and the second data alarm, for example, the first data alarm of the light absorption is a high level data alarm. If the first data alarm is at the high level (Y), the priority output alarm determination unit 60 proceeds to S404, otherwise proceeds to S405 (N).

(S404) The priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result of the light absorption and the first data alarm, and ends this flow.

(S405) The case of proceeding to S405 corresponds to the case where the second data alarm attached to the second measurement result of the scattering is a high level data alarm. Therefore, in S405, the priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result and the second data alarm, and the flow ends.

In the case of the above processing, when a high level data alarm occurs, the measurement has failed and the measurement result is often not obtained. Therefore, in this case, as the output control, only the data alarm may be output without outputting the concentration or the like of the measurement result. If a measurement result is obtained, the measurement result and the data alarm may be output.

Further, as described above, the high level data alarm is added when it is necessary for the user to improve the state of the mechanism, the sample 2, the reagent 4 and the like with respect to an abnormality or the like. Therefore, as described above, when a high level data alarm is added to both measurement results, as shown in S402, all the data alarms are output to alert the user and prompt improvement work. Is desirable. At this time, the above-mentioned system alarm may be output simultaneously with the data alarm.

[(4) Middle level alarm processing]
12 and 13 show the middle level data alarm process of S304. This process is roughly divided into two cases: (a) when both the first data alarm and the second data alarm are at the middle level, and (b) when only the first data alarm is at the middle level And (c) the case where only the second data alarm is at the medium level. FIG. 12 shows the part from step S501 to step S508. FIG. 13 shows the process from step S509 to step S520 as a continuation of FIG.

(S501) The priority output alarm determination unit 60 sets the first data alarm attached to the first measurement result of the absorptiometer 44 and the second data alarm attached to the second measurement result of the scattering photometer 45. The type is further determined based on the above-mentioned classification definition. In S501, the priority output alarm determination unit 60 determines whether or not the first data alarm of the light absorption is a data alarm derived from the high concentration of the sample 2. As the data alarm of this type, the above-mentioned pro zone alarm B1, quantitative range upper limit over alarm B2 and the like correspond. If it is a data alarm of this type (Y), the process proceeds to S502, and if not (N), the process proceeds to S504.

(S502, S503) In S502, the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result and the first data alarm. Then, in S503, the priority output alarm determination unit 60 requires automatic retesting using the absorptiometer 44, and the data of the automatic retesting request information as a condition for reducing the sample amount of the reaction container 25 of the target sample 2 Store in the storage unit 55. The analysis control unit 50 performs automatic retest under the conditions according to the automatic retest request information, stores the result, and causes the output unit 71 to output the result. After S503, the present flow ends.

In the case of S501 to S503, the following judgment and output control are performed. In the first measurement result using the absorptiometer 44 suitable for measurement of high concentration components, when it is determined that the concentration of the target component substance of the sample 2 is too high, a scattering photometer 45 suitable for measurement of low concentration components The reliability of the second measurement result in Therefore, as in S502, only the first measurement result of the light absorption and the first data alarm are output, and as in S503, the automatic retest is performed under the reduced condition. Thereby, the measurement result at the time of re-examination is attempted to be within the suitable quantitative range (the aforementioned normal output range) of the absorptiometer 44.

(S504) The priority output alarm determination unit 60 determines whether the second data alarm for scattering is a data alarm derived from the low concentration of the sample 2. As the data alarm of this type, the aforementioned quantitative range lower limit over alarm B3 corresponds. If it is a data alarm of this type (Y), the process proceeds to S505; otherwise (N), the process proceeds to S507.

(S505, S506) In S505, the priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result of the scattering and the second data alarm. Then, in S506, the priority output alarm determination unit 60 requires automatic retesting using the scattered light clock 45, and makes data on automatic retest request information as a condition for increasing the sample amount of the reaction container 25 of the target sample 2 Store in the storage unit 55. The analysis control unit 50 performs automatic retest under the conditions according to the automatic retest request information, stores the result, and causes the output unit 71 to output the result. After S506, the present flow ends.

In the case of the above S504 to S506, the following determination and output control are performed. In the second measurement result using the scattering photometer 45 suitable for measurement of low concentration components, when it is determined that the concentration of the target component substance of the sample 2 is too low, an absorptiometer 44 suitable for measurement of high concentration components The reliability of the first measurement result in Therefore, as in S505, only the second measurement result of the scattering and the second data alarm are output, and as in S506, the automatic retest is performed under the increased condition. Thereby, the measurement result at the time of re-examination is attempted to be within the suitable quantitative range of the scatterometer 45 or the absorptiometer 44.

(S507) The priority output alarm determination unit 60 determines whether or not the second data alarm of the second measurement result of the scattering is a low level data alarm. The above-described serum information alarm C1 or the like corresponds to this type of data alarm. If the level is low (Y), the process proceeds to S508, and if not (N), the process proceeds to S509 (FIG. 13).

(S508) The priority output alarm determination unit 60 causes the output unit 71 to output the second measurement result of the scattering and the second data alarm. In this case, the second measurement result is output as a reference value, and the flow is ended without performing the automatic retest as unnecessary.

In the case of S508, as a combination of two types of data alarms, a data alarm derived from reaction process abnormality or a data alarm derived from low concentration of the sample 2 is added to the first measurement result, and the second measurement result is added. This corresponds to the situation where a low level data alarm is attached. In this combination, at least one of the sample 2 and the reagent 4 used for the measurement has a cause of generating a low level data alarm. Moreover, in this combination, the concentration of the target component substance of the sample 2 was lower than the lower limit value of the quantitative range of the absorptiometer 44. Therefore, although it could be quantified by the scattering photometer 45, it could not be quantified by the absorptiometer 44 because the concentration was low. As a result, it is considered that such a combination has occurred. That is, in the case of this combination, it can be determined that the measurement itself using the scattering photometer 45 was performed normally. Therefore, in this case, the second measurement result of the scattering is output as a reference value, and the automatic retest is not performed.

(S509) In S509 of FIG. 13, the priority output alarm determination unit 60 determines whether or not the second data alarm of the second measurement result using the scattering photometer 45 is an alarm derived from the high concentration of the sample 2 judge. If it is the type of data alarm (Y), the process proceeds to S510, and if not (N), the process proceeds to S513.

(S510) The priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result and the first data alarm using the absorptiometer 44.

(S511) Further, the priority output alarm determination unit 60 determines whether or not the first data alarm is an alarm derived from an abnormality in the reaction process. If it is the type of data alarm (Y), the process proceeds to S516, and if not (N), the process proceeds to S512.

(S516) The priority output alarm determination unit 60 requires automatic retest, and the data of the automatic retest request information under the same condition as the previous condition in which an abnormality or the like represented by the first data alarm (ie, reaction process abnormality or the like) occurs is Store in the storage unit 55. In the case of S516, as a combination of data alarms, a data alarm derived from reaction process abnormality is added to the first measurement result, and a data alarm derived from high concentration of the sample 2 is added to the second measurement result. The corresponding status is In this case, the concentration of the target component substance of the sample 2 exceeds the upper limit value of the quantitative range of the scattering photometer 45, and the absorptiometer 44 can determine that the measurement has failed. Therefore, in this case, remeasurement is performed under the same conditions as the previous time. The automatic analyzer 1 confirms whether the concentration of the target component substance of the sample 2 falls within the quantitative range of the absorptiometer 44 as a result of the automatic retest. Under the present circumstances, when the case where automatic re-examination is carried out on the conditions which reduce sample volume is considered, it may fall below the quantitative range of the scattering photometer 45. Therefore, automatic re-examination is performed under the same conditions as the previous one. After S516, the present flow ends.

(S512) When the process proceeds to S512, the priority output alarm determination unit 60 further determines whether the first data alarm of the light absorption is an alarm derived from the low concentration of the sample 2. If it is the type of data alarm (Y), the process proceeds to S506; otherwise (N), the flow is ended without performing the automatic retest as unnecessary.

In the case where the process proceeds from step S512 to step S506, the automatic re-examination is performed under the condition of increasing the amount of sample, as described above. In this case, as the combination of the data alarm, the second measurement result exceeds the upper limit value of the quantitative range of the scattering photometer 45, and the first measurement result falls below the lower limit value of the quantitative range of the absorptiometer 44 Is the case. In this case, there is a high possibility that measurement has failed in both of the two photometers. Therefore, as described above, re-measurement is performed under the same conditions to try to obtain a normal result.

In the case where the process ends from the above S512 without automatic retesting in the case (N), the data alarm derived from the high concentration of the sample 2 is added to the second measurement result as the combination of the data alarm, and the first measurement This corresponds to the situation where a low level data alarm is attached to the result. This combination corresponds to at least one of the sample 2 and the reagent 4 used for measurement having a cause of generating a low level data alarm. Furthermore, although this combination could not be quantified by the scattering photometer 45 because the concentration of the target component substance of the specimen 2 exceeds the upper limit value of the quantitative range of the scattering photometer 45, it can be quantified by the absorptiometer 44 Respond to Therefore, it is considered that this combination has occurred. That is, in the case of this combination, it can be determined that the measurement was normally performed in the first measurement result. Therefore, in this case, the first measurement result of the light absorption is output as a reference value, and the automatic retest is not performed.

(S513) The priority output alarm determination unit 60 determines whether or not the first data alarm for light absorption is a data alarm derived from a reaction process abnormality. If it is the type of data alarm (Y), the process proceeds to S514, and if not (N), the process proceeds to S518.

(S514) The priority output alarm determination unit 60 selects one of the measurement result and data alarm to be output preferentially from the two types of measurement result and data alarm according to the "priority output setting" set as a parameter in advance. Make it output. At this time, the priority output alarm determination unit 60 determines with reference to the setting value of the above-mentioned priority output setting information. If the setting value is a value representing "light absorption priority setting" (A), the process proceeds to S515, and if the value is a value representing "scattering priority setting" (B), the process proceeds to S517. As described above, in the "light absorption priority setting", the absorptiometer 44 is set as a photometer whose priority output order is higher than that of the scattered light clock 45. In the "scattering priority setting", the opposite priority output order is set.

(S515) The priority output alarm determination unit 60 selects the first measurement result of the absorptiometer 44 and the first data alarm according to the “absorption priority setting”, and causes the output unit 71 to output the first data alarm. After S515, the process proceeds to S516.

(S517) The priority output alarm determination unit 60 selects the second measurement result of the scattering photometer 45 and the second data alarm according to the “scattering priority setting”, and causes the output unit 71 to output the same. After S517, the process proceeds to S516.

(S516) After S515 or S517, in S516, the priority output alarm determination unit 60 requires an automatic retest, and makes an automatic retest request under the same conditions as the previous time. That is, the priority output alarm determination unit 60 stores, in the data storage unit 55, automatic retest request information that is the same remeasurement condition as the condition when an abnormality or the like indicated by the data alarm occurs.

The combination of data alarms in the case of S513 to S517 corresponds to a state in which data alarms originating from reaction process abnormalities are added to both the first measurement result and the second measurement result. In this case, it can be determined that measurement has failed in both of the two photometers. Therefore, in this case, basically, measurement results and data alarms of any of two types of photometers may be output. Therefore, in the above processing example, one measurement result and data alarm are selected based on the determination of "priority output setting" in S514, and automatic re-examination under the same conditions as the previous time is performed in S516 to obtain a normal result. I'm trying.

(S518, S519) In S518, the priority output alarm determination unit 60 causes the output unit 71 to output the first measurement result of the light absorption and the first data alarm. Furthermore, in S519, the priority output alarm determination unit 60 determines whether or not the first data alarm is an alarm derived from the low concentration of the sample 2. If it is the type of data alarm (Y), the process proceeds to S520; otherwise (N), the flow is ended without performing the automatic retest.

(S520) The priority output alarm determination unit 60 stores, in the data storage unit 55, automatic retest request information under the condition of increasing the sample amount, and causes the automatic retest to be performed.

In the combination of data alarms in the case of the above S518 to S520, a data alarm derived from reaction process abnormality is added to the second measurement result, and a data alarm derived from low concentration of the sample 2 is added to the first measurement result. State is applicable. In this case, the scattering photometer 45 can determine that the measurement has failed. Therefore, in S519, the first measurement result of the light absorption and the first data alarm are output, and in S520, the automatic retest is performed. Thereby, the measurement result at the time of the automatic retest is trying to be in the quantitative range of the absorptiometer 44.

In the case where the process is not performed in S519 (N) and the process is ended without performing the automatic retest, a data alarm derived from the reaction process abnormality is added to the second measurement result as the combination of the data alarm, and the first measurement result The situation where the low level data alarm is attached is In this case, it can be determined that the measurement has failed in the scattering photometer 45, and the measurement itself has ended normally in the absorptiometer 44. Therefore, in this case, the first measurement result is output as a reference value in S519, the first data alarm is output, and the automatic retest is not performed.

[(5) Low level alarm processing]
FIG. 14 shows the low level data alarm process of S305. FIG. 14 has steps S601 to S607. The steps will be described in the following order.

(S601) The priority output alarm determination unit 60 determines the first data alarm attached to the first measurement result of the absorptiometer 44 and the second data alarm attached to the second measurement result of the scattering photometer 45. Check whether both are low level data alarms. If both are low level (Y), the process proceeds to S602; otherwise (N), the process proceeds to S605.

(S602) The priority output alarm determination unit 60 performs priority output determination based on the "priority output setting", and selects and outputs one of the measurement results and data alarms to be preferentially output. The priority output alarm determination unit 60 proceeds to S603 if the “scattering priority output” is (B), and proceeds to S604 if the “light absorption priority output” is (A).

(S603) The priority output alarm determination unit 60 selects the second measurement result and the second data alarm according to the “scattering priority output”, and causes the output unit 71 to output the same. Thereafter, the flow is ended without performing the automatic retest.

(S604) The priority output alarm determination unit 60 selects the first measurement result and the first data alarm according to the “absorptive light priority output” and causes the output unit 71 to output the result. Thereafter, the flow is ended without performing the automatic retest.

(S605) The priority output alarm determination unit 60 confirms whether only the first data alarm for light absorption is at a low level. If only the first data alarm is low (Y), the process proceeds to S606, otherwise (N), that is, if only the second data alarm for the scattering is low, the process proceeds to S607.

(S606) The priority output alarm determination unit 60 selects the first measurement result of the light absorption and the first data alarm, and causes the output unit 71 to output the result. Thereafter, the flow is ended without performing the automatic retest.

(S607) The priority output alarm determination unit 60 selects the second measurement result of the scattering and the second data alarm, and causes the output unit 71 to output the result. Thereafter, the flow is ended without performing the automatic retest.

As described above, in the case of each combination including a low level data alarm, it can be determined that the measurement itself has ended normally, so the measurement result is output as a reference value and automatic retest is not performed.

[Effects, etc.]
As described above, the automatic analyzer 1 according to the first embodiment includes the two types of photometers of the absorptiometer 44 and the scattering photometer 45, and uses two types of photometers for the target component substance of each inspection item. Perform simultaneous analysis. The automatic analyzer 1 refers to two types of data alarms that can be added to two types of measurement results. Then, when there are two types of data alarms caused by an abnormality or the like at the time of measurement in both of the two types of measurement results, the automatic analyzer 1 outputs suitable measurements according to the combination of those data alarms. Select the result and data alarm etc. As described above, even when there is an abnormality or the like in measurement using two types of photometers, the automatic analyzer 1 performs output control so as to limit and reduce the amount of information of analysis result output to the user. As a result, according to the automatic analyzer 1, more accurate analysis results can be obtained by simultaneous analysis than in the prior art example, and even when there are abnormalities or the like during measurement, the user's judgment or operation on the analysis results output Can reduce the load on As the user, when viewing the analysis result output on the display screen, information such as suitable measurement results and data alarms are automatically selected and limited, so recognition and judgment of the state are easy, and the handling work It is easy to do. As a result, it is possible to prevent the user from making a mistake and to prevent the result report delay.

In addition, even when there is an abnormality or the like at the time of measurement using two types of photometers, the automatic analyzer 1 automatically performs suitable automatic re-examination control according to the combination of data alarms. The automatic analyzer 1 determines the necessity and conditions of the automatic re-examination so as to reflect at least one of the device state and the sample component state, even when there is an abnormality or the like in both of the two types of measurement. The automatic analyzer 1 determines the necessity and conditions of the suitable automatic retest according to the combination, controls the automatic retest, and outputs the result. Therefore, the automatic re-examination function of the automatic analysis device 1 can be effectively used, more accurate results (concentration and the like) can be obtained in a shorter time by the automatic re-examination, and delay in reporting results by the user can be prevented.

[Modification (1)]
The following can be mentioned as a modification of the automatic analyzer 1 of the first embodiment. Although the case where two types of two photometers are provided has been described in the first embodiment, the present invention is not limited to this, and the invention is similarly applicable to the case where three or more types of three or more photometers are provided. The present invention is also applicable to the case where a plurality of photometers of a certain type are provided. For example, if three photometers are provided, simultaneous analysis using three photometers may be performed. Alternatively, simultaneous analysis may be performed using two types of photometers selected according to settings and an analysis request among the three types. The output selection control may be similarly performed in association with a combination of a plurality of data alarms added to the plurality of measurement results.

[Modification (2)]
In the first embodiment, the data alarm corresponding to abnormality or the like is roughly classified into three groups and levels, and it has been described that different output control is performed according to the combination thereof. The classification of the data alarm is not limited to three. As shown in the correspondence table, it may be a configuration in which an association of output selection including the measurement result and the data alarm is defined for each combination of data alarms related to the measurement results of a plurality of types of photometers.

[Modification (3)]
In the first embodiment, if there is a combination of two types of measurement results and data alarms that cause no problem even if either information is output, there is little problem with “Priority output setting”. Based on the information, one of the information is selected and output. Not limited to this, as a modified example, in the case of the specific combination as described above, the "priority output setting" function may not be used. In this modification, based on a fixed setting on implementation, in the case of the specific combination as described above, only one specified information is output or both information is output.

[Modification (4)]
In the above-described flow diagrams, one example of the processing order in the output control process is shown, but the present invention is not limited to this. For example, it is of course possible to adopt a processing flow in which the order of determination of types such as levels and abnormalities is changed. The following is also possible as a modification of the processing flow configuration of the first embodiment. In step S507 of the middle level data alarm process of FIG. 12, the following step S507-1 is provided before proceeding to step S508 according to the determination result (Y). In step S507-1, it is determined whether a low level data alarm is attached to the first measurement result of the light absorption. If it is noted (Y), the process proceeds to step S601 in FIG. 14, and if it is not (N), the process proceeds to step S508. That is, in the case of this flow configuration, middle level data alarm processing and low level data alarm processing are realized as one flow diagram. In this case, in the process flow of FIG. 10, only the determination regarding the high level in S301 is performed. When the high level is included in S301 (Y), the high level data alarm processing of S302 is performed, and when the high level is not included (N), the above middle level and low level processing are integrated. Processing flow is performed.

Second Embodiment
The automatic analyzer according to the second embodiment of the present invention will be described with reference to FIG. The basic configuration in the second embodiment and the like is the same as that in the first embodiment, and in the following, components different from the first embodiment in the second embodiment and the like will be described.

Processing flow
In the first embodiment, data alarms related to a plurality (two types) of photometers are classified into the above three groups and levels. The middle level was further classified into (B-1) data alarm derived from reaction process abnormality and (B-2) data alarm derived from specimen concentration abnormality. In addition, data alarms derived from abnormal sample concentration were classified into data alarms derived from high concentration and data alarms derived from low concentration. Then, as shown in FIG. 5 etc., the output is selected according to the combination of the data alarm.

In the second embodiment, it is not essential to classify data alarms (corresponding abnormalities, errors, etc.) related to a plurality (two types) of photometers into the aforementioned groups and levels, and a plurality of individual data which may occur. You only need to know the alarm. The automatic analyzer according to the second embodiment refers to the individual data alarms appended to the measurement results using the individual photometers on the processing flow, and directly outputs the output according to the combination of those data alarms. select. In the second embodiment, the correspondence between the combination of the data alarm and the output is defined in advance, as in the example of the correspondence table described above. The processing flow in the second embodiment is implemented based on the specification. The analysis control unit 50 refers to data such as two types of measurement results and data alarms stored in the data storage unit 55 as processing results by the analysis unit 52. The analysis control unit 50 determines the combination of the data alarms referred to in the processing flow, and selects the measurement result, the data alarm, and the automatic retest information as the output to be associated according to the combination.

The processing flow configuration of the second embodiment differs from the processing flow configuration of the first embodiment in the contents (FIG. 10 and the like) of the priority output alarm determination processing of step S205 of FIG. 9 described above. FIG. 15 shows a part of a process flow configuration example in the automatic analyzer 1 of the second embodiment. In the case of the output control process regarding simultaneous analysis using two types of photometers, the automatic analyzer 1 performs the process according to the flow as shown in FIG. 15 instead of the flow of FIG. In the flow of FIG. 15, the analysis control unit 50 first determines, for example, whether or not the aforementioned sample shortage alarm A1 is added as a first data alarm to the first measurement result of the absorptiometer 44 in step S151. judge. If it is indicated (Y), the process proceeds to S152. If not indicated (N), the process proceeds to another step (omitted). In S152, the analysis control unit 50 determines whether the second measurement result using the scattering photometer 45 is accompanied by the sample shortage alarm A1 as a second data alarm. If it is indicated (Y), the process proceeds to S153, and if it is not indicated (N), the process proceeds to S154. The case of appending in S152 (Y) corresponds to the case where both are the sample shortage alarm A1 as a combination of two types of data alarms. In S151 and S152, confirmation of such a combination is performed. Assuming that the combination, for example, the first combination, the analysis control unit 50 causes the first data alarm and the second data alarm, which are both two types of data alarms, to be output as an output according to the first combination in S153. . The processing contents at this time are the same as the processing contents at S401 and S402 of the high level data alarm processing of FIG. 11 of the first embodiment.

Also, for example, in S154, the analysis control unit 50 determines whether the above-mentioned reagent shortage alarm A2 is added as the second data alarm of the second measurement result. If it is indicated (Y), the process proceeds to S155, and if not indicated (N), the process proceeds to another step (omitted). That is, in S151 and S154, the combination in which the first data alarm is the inspection shortage alarm A1 and the second data alarm is the reagent shortage alarm A2 is confirmed. The analysis control unit 50 outputs the first data alarm and the second data alarm as an output according to the second combination in S155 if the combination, for example, the second combination.

As in the above process flow example, the automatic analyzer 1 according to the second embodiment determines a corresponding combination of all possible combinations of data alarms for two types of data alarms, and determines the corresponding combination according to the determined combinations. Similarly to the first embodiment, the output is selected based on a predetermined criterion.

As described above, according to the second embodiment, the same effect as the first embodiment can be obtained.

Third Embodiment
The automatic analyzer according to the third embodiment of the present invention will be described with reference to FIGS. In the automatic analyzer 1 according to the third embodiment, not only the data alarm corresponding to the abnormality at the time of measurement is added to each measurement result of the two types of photometers by the determination of the analysis control unit 50 but also automatic retest Automatic re-test information related to the function is created and added. In particular, the analysis unit 52 appends a data alarm according to an abnormality or the like to the measurement result of a certain photometer, and determines the necessity of automatic retest and the remeasurement condition or the like. Then, the analysis unit 52 adds automatic retest information including information such as necessity / unnecessity of automatic retest and remeasurement conditions in association with the information of the target sample 2 or the reaction container 25, the measurement result and the data alarm, and analyzes The data is stored in the data storage unit 55 as data.

A processing unit such as the simultaneous analysis determination unit 56 of the analysis control unit 50 analyzes data including measurement results, data alarms, and automatic retest information related to each of the two types of photometers stored in the data storage unit 55. Refer to Then, the simultaneous analysis determination unit 56 or the like selects an output based on a standard defined in a predetermined correspondence table in accordance with a combination of the data alarm and the automatic retest information in the two types of data. The selected output (ie, analysis result output information) includes measurement results, data alarms, and automatic retest information, as in the first embodiment. As described above, the automatic analyzer 1 of the third embodiment differs from the first embodiment in the processing relating to the automatic reinspection function. As described above, in the third embodiment, the analysis unit 52 temporarily makes a determination regarding the automatic re-examination function for each measurement result of individual photometers, and creates and adds automatic re-examination information. The automatic retest information (retest flag information described below) added by the analysis unit 52 has a different meaning from the above-described automatic retest information. Thereafter, the analysis control unit 50 selects and determines an output including the automatic retest information comprehensively again according to a combination of two types of measurement results including the automatic retest information and the data alarm.

[Auto Retest Information (Retest Flag)]
In the third embodiment, the analysis unit 52 creates and adds automatic retest information (described as retest flag information) of a predetermined format. For example, when adding a first data alarm according to an abnormality at the time of measurement, etc. to the first measurement result using the absorptiometer 44, the analysis unit 52 determines whether or not the automatic retest is necessary, and remeasurement if necessary. Determine the conditions etc. The analysis unit 52 adds automatic retest information (first retest flag) according to the determination result to the first measurement result and the first data alarm. Similarly, when adding the second data alarm according to the abnormality at the time of measurement, etc. to the second measurement result using the scattering photometer 45, the analysis unit 52 determines whether or not the automatic retest is necessary, and if necessary Determine the measurement conditions etc. The analysis unit 52 adds automatic retest information (second retest flag) according to the determination result to the second measurement result and the second data alarm.

The retest flag is a value representing the necessity (presence or absence) of the automatic retest, the remeasurement condition, and the like using the corresponding type of photometer. The analysis unit 52 stores the data including the measurement result, the data alarm, and the retest flag in the data storage unit 55 in such a manner as to associate the measurement value of the object with the analysis request information of the reaction container 25 or the corresponding sample 2 that acquired the measurement value. .

In the third embodiment, the retest flag is classified into the following four according to the type of data alarm. The identifiers of the retest flag are F1 to F4.

(1) First Retest Flag F1 = “No Retest Flag”: The first retest flag F1 indicates that automatic retest is unnecessary (absent). Note that the retest flag itself may not be added instead of the first retest flag F1.

(2) Second retesting flag F2 = "Same condition retesting flag": The second retesting flag F2 needs (represents) automatic retesting, and as a condition, at the time of the previous measurement (ie, an abnormality etc. is detected) Represents the same remeasurement conditions as in

(3) Third retesting flag F3 = "weight loss retesting flag": The third retesting flag F3 indicates that automatic retesting is necessary (present) and that the amount of sample is reduced from the condition at the time of the previous measurement and Represents to do.

(4) Fourth retesting flag F4 = “increased retesting flag”: The fourth retesting flag F4 indicates that automatic retesting is necessary (present) and that the amount of sample is increased relative to the condition at the time of the previous measurement and Represents to do.

The processing flow in the third embodiment is similar to, for example, the level determination process of FIG. 10 of the first embodiment and the high level data alarm process of FIG. 11 described above.

Processing flow
FIG. 16 and FIG. 17 show the flow of middle level data alarm processing by the analysis control unit 50 (particularly the simultaneous analysis determination unit 56 etc.) in the third embodiment. FIG. 16 shows steps S701 to S708. FIG. 17 shows step S709 to step S720 following FIG. This process is performed when the middle level data alarm is included in the data alarms appended to the two types of measurement results as in the flow of step S304 in FIG. In the processing example of FIG. 16, the output is selected based on the determination of the retest flag.

(S701) The analysis control unit 50 determines whether or not the “decreased retest flag” (third retest flag F3) is added as a retest flag to the first measurement result and the first data alarm of the absorptiometer 44. . If it is added (Y), the processing proceeds to S702, and if it is not added (N), the processing proceeds to S704.

(S702, S703) In S702, the analysis control unit 50 causes the output unit 71 to output the first measurement result and the first data alarm. Then, in S703, the analysis control unit 50 determines that the automatic re-examination is necessary, and stores, in the data storage unit 55, the automatic re-examination request information as a condition for reducing the sample amount from the previous condition. The analysis control unit 50 controls the automatic retest according to the automatic retest request information, and outputs the result. After S703, the present flow ends.

The above-mentioned “weight re-examination flag” (third re-examination flag F3) is added when the concentration of the target component substance of the sample 2 is too high. If the concentration of the target component substance of the sample 2 is determined to be too high (for example, exceeding the upper limit value of the quantitative range) in the first measurement result using the absorptiometer 44 suitable for measuring the high concentration component, the low concentration The reliability of the second measurement result using the scattering photometer 45 suitable for the measurement of the component is also low. Therefore, in this case, the first measurement result is output, and the automatic re-examination is performed under the condition of reducing the amount as described above. Thereby, the measurement result at the time of re-examination is attempted to be within the quantitative range of the absorptiometer 44.

(S704) The analysis control unit 50 determines whether the “increase retest flag” (the fourth retest flag F4) is added to the second measurement result and the second data alarm of the scattering photometer 45. If it is added (Y), the processing proceeds to S705, and if it is not added (N), the processing proceeds to S707.

(S705, S706) At S705, the analysis control unit 50 causes the output unit 71 to output the second measurement result and the second data alarm. Then, in S706, the analysis control unit 50 stores, in the data storage unit 55, automatic retest request information as a condition for increasing the sample amount with respect to the previous condition. The analysis control unit 50 controls the automatic reexamination according to the automatic reexamination request information. After S705, this flow ends.

The above-mentioned “increase re-examination flag” (fourth re-examination flag F4) is added when the concentration of the target component substance of the sample 2 is too low. In the second measurement result using the scattering photometer 45 suitable for measurement of low concentration components, if it is determined that the concentration of the target component substance of the sample 2 is too low (for example, lower than the lower limit value of the quantitative range), high concentration The reliability of the first measurement result using the absorptiometer 44 suitable for the measurement of the component is low. Therefore, in this case, the second measurement result is output, and the automatic retest is performed under the condition of increasing the amount as described above. Thereby, the measurement result at the time of re-examination is attempted to be within the quantitative range of the scatterometer 45 or the absorptiometer 44.

(S 707) The analysis control unit 50 determines whether or not the “No retest flag” (first retest flag F 1) is added to the second measurement result and the second data alarm. Alternatively, this step S 707 may be confirmation as to whether or not the retest flag itself is added. If it is added (Y), the process proceeds to S708, and if it is not added (N), the process proceeds to S709.

(S708) The analysis control unit 50 causes the output unit 71 to output the second measurement result and the second data alarm, and does not perform the automatic retest, and ends the present flow after S708.

(S709) When proceeding to S709 in FIG. 17, as the retest flag associated with the second measurement result, “weight loss retest flag” (third retest flag F3) or “same retest flag” (second retest flag F2) It corresponds to a case. In S709, the analysis control unit 50 determines whether the “decrease retest flag” (third retest flag F3) is added to the second measurement result and the second data alarm. If it is added (Y), the process proceeds to S710, and if it is not added (N), the process proceeds to S713.

(S710) The analysis control unit 50 causes the output unit 71 to output the first measurement result of the absorptiometer 44 and the first data alarm.

(S711) Further, the analysis control unit 50 determines whether or not the same condition retest flag (second retest flag F2) is added to the first measurement result. If it is added (Y), the process proceeds to S716, and if it is not added (N), the process proceeds to S712.

(S716) The analysis control unit 50 stores, in the data storage unit 55, automatic retest request information under the same conditions as the conditions at the time of the previous measurement. The analysis control unit 50 controls the automatic reexamination according to the automatic reexamination request information. After S716, this flow ends.

(S712) Further, when the process proceeds to S712, the analysis control unit 50 further determines whether the increase re-examination flag (the fourth re-examination flag F4) is added to the first measurement result. If it is added (Y), the process proceeds to S706, and if it is not added (N), the flow is ended without performing the automatic retest.

(S713) The analysis control unit 50 determines whether the condition retest flag (second retest flag F2) is added to the first measurement result. If it is added (Y), the process proceeds to S714, and if it is not added (N), the process proceeds to S718.

(S714) The analysis control unit 50 performs priority output determination in accordance with “priority output setting”. If it is “absorptive output priority” (A), the process proceeds to S715, and if it is “scattering priority output” (B), the process proceeds to S717.

(S 715) The analysis control unit 50 causes the output unit 71 to output the first measurement result using the absorptiometer 44 and the corresponding first data alarm according to the “absorbance priority output”.

(S717) The analysis control unit causes the output unit 71 to output the second measurement result using the scattering photometer 45 and the corresponding second data alarm according to the “scattering priority output”.

(S716) After S715 or S717, in S716, the analysis control unit 50 stores, in the data storage unit 55, automatic retest request information that is the same as the condition at the time of the previous measurement.

(S 718) The analysis control unit 50 causes the output unit 71 to output the first measurement result and the first data alarm using the absorptiometer 44.

(S719) Further, the analysis control unit 50 determines whether the increase re-examination flag (the fourth re-examination flag F4) is added to the first measurement result. If it is added (Y), the process proceeds to S720, and if it is not added (N), the flow is ended without performing the automatic retest.

(S720) The analysis control unit 50 stores, in the data storage unit 55, automatic retest request information as a condition for increasing the sample amount with respect to the previous condition. After S720, this flow ends.

As in the above processing example, in the third embodiment, according to the combination of the measurement result, the data alarm, and the retest flag for each type of photometer, the output (measurement result, data alarm, and automatic Select retest information). Thereby, even when there is an abnormality or the like in both of the two types of measurement, the automatic re-examination can be appropriately controlled to promptly perform the re-measurement. Therefore, more accurate results can be obtained, and delay in reporting results can be prevented.

The following method may be used, for example, when determining the condition for decreasing the amount of sample or the condition for increasing the amount as a remeasurement condition or the like which is a condition of the automatic retest. As the method, using a value such as a predetermined amount or a ratio set in advance, the value of the predetermined amount or the ratio is reflected on the value of the previous condition by addition or multiplication. Determine the sample volume etc. Alternatively, as another method, some candidate sample amount conditions may be defined and set in advance, and the sample amount of the remeasurement condition may be determined by selecting and switching from these conditions. .

As mentioned above, although this invention was concretely demonstrated based on embodiment, this invention is not limited to above-mentioned embodiment, It can change variously in the range which does not deviate from the summary.

DESCRIPTION OF SYMBOLS 1 ... Automatic analyzer, 2 ... specimen, 3 ... reaction liquid, 4 ... reagent, 25 .. reaction container, 44 ... absorption spectrophotometer, 45 ... scattering photometer, 50 ... analysis control part.

Claims

A plurality of types of photometers having different quantification ranges, and an analysis control unit that controls analysis including measurement using the plurality of photometers for a target sample;
The analysis control unit
Obtaining a plurality of measurement results including a plurality of measurement values using the plurality of photometers;
When an abnormality is detected in the measurement using the plurality of photometers, a data alarm corresponding to the type of the abnormality is displayed on the measurement result using the corresponding photometer among the plurality of measurement results. Note,
When a plurality of data alarms are attached to the plurality of measurement results, the measurement results and data to be output corresponding to the combination of the plurality of data alarms from the plurality of measurement results and the plurality of data alarms Selecting an alarm and outputting the selected measurement result and the data alarm to the user as an analysis result;
Automatic analyzer.
In the automatic analyzer according to claim 1,
The analysis control unit is responsive to a combination of the plurality of data alarms, whether or not it is necessary to perform an automatic retest on the target sample, a type of photometer used in the automatic retest, and a remeasurement condition in the automatic retest. And selecting automatic re-examination information, and controlling the automatic re-examination according to the automatic re-examination information,
Automatic analyzer.
In the automatic analyzer according to claim 2,
The data alarms are classified into multiple levels: high level, medium level, low level,
The high level is a level requiring the automatic retest and requiring the user to improve the state for the automatic retest.
The middle level is a level that requires the automatic retest and does not require the user to improve the state for the automatic retest.
The low level is a level at which the automatic retest is unnecessary.
The analysis control unit determines the level of the combination of the data alarms, and selects the automatic re-examination information to be output corresponding to the level.
Automatic analyzer.
In the automatic analyzer according to claim 3,
The high level data alarm includes at least one of a sample shortage alarm, a reagent shortage alarm, a blockage detection alarm, a detergent shortage alarm, and a photometer abnormality alarm.
Automatic analyzer.
In the automatic analyzer according to claim 3,
The medium-level data alarm includes a data alarm derived from reaction process abnormality and a data alarm derived from sample concentration abnormality,
The data alarm derived from the reaction process abnormality includes at least one of a cell blank abnormality alarm, an absorbance difference abnormality alarm, and a scattered light intensity difference abnormality alarm,
The data alarm derived from the sample concentration abnormality includes at least one of a pro zone alarm, a quantitative range upper limit alarm, and a quantitative range lower limit alarm.
Automatic analyzer.
In the automatic analyzer according to claim 3,
Having at least one of a serum information alarm and a reagent expiration alarm as the low level data alarm,
Automatic analyzer.
In the automatic analyzer according to claim 2,
The analysis control unit
Re-examination flag information for controlling the automatic re-examination is added to the measurement result for each type of the photometer based on the result of making the determination regarding the automatic re-examination together with the determination of appending the data alarm,
The analysis result including the measurement result, the data alarm, and the automatic retest information to be output is selected according to a combination of a plurality of retest flag information added to the plurality of measurement results.
Automatic analyzer.
In the automatic analyzer according to claim 1,
As the priority output setting, it is set in advance which one of the plurality of photometers is to be used as the priority output,
The analysis control unit, in the case of a specific combination as the combination of the data alarms, selects the measurement result to be output and the data alarm according to the priority output setting.
Automatic analyzer.
In the automatic analyzer according to claim 1,
The order according to the importance is set to a plurality of data alarms that can occur as the data alarm,
The analysis control unit appends one data alarm selected according to the importance when appending the data alarm for the measurement result for each type of the photometer.
Automatic analyzer.
In the automatic analyzer according to claim 2,
As the remeasurement conditions, the same conditions as those of the previous measurement, conditions for reducing the amount of sample, and conditions for increasing the amount of sample,
Automatic analyzer.
In the automatic analyzer according to claim 1,
The plurality of types of photometers include an absorptiometer and a scattering photometer.
Automatic analyzer.
An automatic analysis method in an automatic analyzer,
The automatic analyzer includes a plurality of types of photometers having different quantification ranges, and an analysis control unit that controls analysis including measurement using the plurality of photometers for a target sample.
As a step executed in the analysis control unit,
Obtaining a plurality of measurement results including a plurality of measurements using the plurality of photometers;
When an abnormality is detected in the measurement using the plurality of photometers, a data alarm corresponding to the type of the abnormality is displayed on the measurement result using the corresponding photometer among the plurality of measurement results. Additional steps,
When a plurality of data alarms are attached to the plurality of measurement results, the measurement results and data to be output corresponding to the combination of the plurality of data alarms from the plurality of measurement results and the plurality of data alarms Selecting an alarm and outputting the selected measurement result and the data alarm to a user as an analysis result;
Have an automatic analysis method.
In the automatic analysis method according to claim 12,
The analysis control unit corresponds to the combination of the plurality of data alarms, whether or not it is necessary to perform an automatic retest on the target sample, the type of photometer used in the automatic retest, and the remeasurement condition in the automatic retest. And selecting automatic re-examination information, and controlling the automatic re-examination according to the automatic re-examination information,
Automatic analysis method.